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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
Acronyme du projet/
Acronym of the project

F-CRIN

Titre du projet en français

Plateforme Nationale d'Infrastructures de Recherche Clinique

Project title in English

French Clinical Research Infrastructure Network

Coordinateur du
projet/Coordinatorof the
project

Nom / Name :
Etablissement / Institution :
Laboratoire / laboratory :
Numéro d’unité/unit number :
Tranche 1/Phase 1
22 622 000€

Aide demandée/
Requested funding
Domaines scientifiques/
scientific area

Olivier RASCOL
Inserm / CHU de Toulouse /
Université de Toulouse
CIC de Toulouse
CIC9302
Tranche 2/Phase 2
1 589 120€

Recherche Clinique / Clinical Research

Affiliation(s) du partenaire coordinateur de projet/ Organization of the coordinating
partner
Laboratoire(s)/Etablissement(s)
Laboratory/Institution(s)
Centre d’Investigation Clinique de
Toulouse

Numéro(s) d’unité/
Unit number

Tutelle(s) /Research
organization reference

CIC9302

Inserm, CHU de Toulouse

Affiliations des partenaires au projet/Organization of the partner(s)
Laboratoire(s)/Etablissement(s)

Numéro(s) d’unité/

Laboratory/Institution(s)

Unit number

Entreprise(s) / company

Secteur(s) d’activité/activity
field

1 /309

Tutelle(s)/Research
organization reference

Effectif/ Staff size

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
CONTENT
1. SUMMARY

4

2. CONTEXT: SCIENTIFIC ENVIRONMENT AND POSITIONING
OF THE INFRASTRUCTURE PROJECT
2-1 The development of clinical research infrastructures
2-2 The CIC network and DIRCs on the national and ESFRI roadmaps
2-3 International benchmarking
a) Support to investigation
b) Support to study management
c) Support to sponsors
2-4 Current situation in France
a) Sponsors
b) Clinical trials units and data centres
c) Support to investigation

8
8
8
9
9
10
10
11
12
12
12

3. PROJECT MANAGEMENT
3-1 Management
a) Relevant experience of the project coordinator
b) Coordination modalities
3-2 Collaboration organization
a) Partners description, relevance and complementarity
b) Complementarities and add value of the different partners
c) Successful joint initiatives already implemented in collaboration
between F-CRIN partners to support clinical research in France

14
14
14
15
16
16
19

4. TECHNICAL AND SCIENTIFIC DESCRIPTION OF THE ACTIVITIES
4-1 General Overview
4-2 Presentation of the different Work Packages (WP)
WP1 Governance and management
WP2 Evaluation
WP3 Coordination of services and one-stop shop access
at the national level
WP4 Development of common tools
WP5 Training and communication
WP6 Investigation networks
WP7 Clinical trial units
WP8 Data centers
WP9 Europe, connection to ECRIN

22
22
23
25
28

5. TRAINING, DISSEMINATION AND EXPLOITATION OF RESULTS
5-1 Expected impacts of the project
a) Impact on academic research
b) Impact on industry-sponsored clinical trials
c) Impact on healthcare
d) Impact on economy
5-2 Dissemination and/or exploitation of project results,
and management of intellectual property
a) Dissemination of foreground within F-CRIN
b) Dissemination of foreground outside F-CRIN
5-3 Training of the students and scientific community
5-4 Management of Intellectual property and exploitation of Foreground

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51

2 /309

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
6. FINANCIAL ASSESSMENT

59

7. APPENDICES
7-1 References
7-2 List of acronyms
7-3 List of publications form Pr Olivier Rascol
7-4 List of publications from the Clinical Investigation Centers
7-5 Business plan of the ECRIN-ERIC

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271

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APPEL A PROJETS
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2010

Acronyme du projet / Acronym:

F-CRIN
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1. SUMMARY
Clinical research requires professional, multidisciplinary infrastructures providing
support to investigation, to study management, and to sponsors in clinical studies.
Strengthening the attractiveness and competitiveness of this infrastructure is a major
economic challenge: clinical development is by far the highest industry investment in
the biomedical area (2.5 Bn€/year); the FP7 now invests 150M€/year in clinical trials; and
clinical research results in major cost containment in the health systems. France had a
pioneering experience in Europe with the creation in most University Hospitals, since 1992,
of Clinical Investigation Centers (CIC) providing support to investigation, particularly in
experimental medicine and early phase studies. This was achieved in partnership between
INSERM and the Ministry of Health. In parallel, the Ministry of Health created in the early
90’s, in University Hospitals too, structures designed to sponsor and coordinate clinical
research at the local (DRCI) and later (2006) at the interregional level (DIRC). These
infrastructures have now matured and expanded their activity, although not necessarily in
a concerted manner. They form a nationwide network that is listed on the national
roadmap for research infrastructures (TGIR) and represents the national component of the
ESFRI-roadmap infrastructure for clinical research (ECRIN), whose coordination is hosted
by France. ECRIN now plays a major role in facilitating multinational clinical trials, and
since 2010 the FP7 Health priority invests about 150M€/year in funding large scale,
multinational investigator-driven clinical trials. European countries will now compete for this
funding.
In the context of a growing European competition, there is an urgent need to improve
the effectiveness of the French national system and especially its capacity to support
large-scale multi-centric multinational academic clinical trials. Similarly, it is also
crucial to increase the attractiveness of France for early development Proof-of-Concept
studies sponsored by the pharmaceutical industry. A common analysis made by the 3
academic key players involved into clinical research in France (INSERM, University
Hospitals and all Universities attached to these hospitals) is that reaching such goals
requires 2 main investments:
(1) developing or up-grading a combination of the structures that are currently
insufficiently mature or too fragmented in France including: (a) nationwide diseaseoriented investigator networks to support investigation, (b) clinical trial units reaching

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
the critical size to efficiently support study design, management and analysis and (c)
professional data centres. This should be achieved without necessarily adding new
structures, but when possible through incentives to transform, adapt, merge and
coordinate existing units to meet these strategic goals;
(2) coordinating and simplifying a fragmentized and heterogeneous system preventing
rapid and efficient adaptations.
The F-CRIN program takes advantage of these common views, which are in line with the
recent analysis made by the French pharmaceutical industry (LEEM/ARIIS), to propose a
collaborative approach for a more efficacious and competitive implementation and
management of multi-centric and international clinical studies, from early
translational

proof-of-concept

aspects

(a

major

opportunity

for

the

French

pharmaceutical industry) to large multicentric clinical/epidemiological trials (a field left
behind the time in many areas according to many academic investigators and sponsors).
To achieve such goals, the F-CRIN infrastructure proposes to invest within 2 consecutive
phases:
- During the first 24 months of the project (phase I), a first investment will be dedicated to
implementing or up-grading the 3 identified clinical research facilities (diseaseorientated clinical Networks, Trial Units (CTUs) and Data Centres) through specifications
and competitive calls. In parallel, during the same phase I, investment will be dedicated to
setting-up a coordinated and transparent infrastructure: the F-CRIN “hub”. The
definition of governance and management of services will be proposed by the 3 partners of
the project and will define common rules for access to the facilities and common
procedures

of

functioning

including

quality

assurance,

study

management,

pharmacovigilance, monitoring, auditing, etc…
- During phase II (month 24 to 60), once the F-CRIN services infrastructure is established,
the last part of the investment will be dedicated to the practical implementation of the
infrastructure. This phase is mandatory in order to test, improve and demonstrate F-CRIN
efficiency through the first studies using its services, and before allowing the infrastrucutre
living its own life. The quantitative objective of this phase is to achieve the technical and
scientific management of at least 5 multi-centric research projects funded by the EU
(instead of none nowadays) and 15 multicentric early phase clinical trials in
partnership with pharmaceutical companies (including SMEs). At the end of this 5-year

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
time, F-CRIN costs will be covered by the resources generated through the services
provided by its users (national or international academic grants or industrial budgets).
Practically, the F-CRIN project is based on 9 strongly interdependent work packages
(WP). WP1 will manage the program and define the governance and management for
this national clinical research “hub” infrastructure, whereas WP2 will define its evaluation
from the scientific, technical and quality assurance perspective, and WP3 will define
common procedures for access to coordinated services. In parallel, WP4 will develop
common tools and procedures for QA, study management, pharmacovigilance,
monitoring, and interface with the industry and biobank initiatives, and will develop and
maintain regulatory, ethical and GCP know-how. WP5 will address training issues, first
providing a directory of existing training programs in France and then coordinating
collective initiatives between the different partners to propose a comprehensive offer in
that field. Based on this governance framework (WP1-3) and on specifications derived
from the common tools and procedures (WP4), the project will also allow specifications for
developing or upgrading structures supporting investigation to be launched via
competitive calls for the creation / upgrade of about 10 to 12 nationwide diseaseoriented investigator networks (WP6), a restricted number (5 to 7) of disease-oriented
clinical trial units selected on scientific excellence and reaching the critical size (WP7),
and a few (3 to 5) professional data centres providing high quality services based on
leading edge technology (WP8). This will enable an efficient connection of the French
clinical research infrastructure to the pan-European infrastructure ECRIN (WP9),
structuring a clinical research capacity best adapted for large-scale trials and multinational
collaboration, and fostering the national participation in, and coordination of multinational
clinical trials now funded by the FP7.
This major upgrade of this clinical research infrastructure is expected to result in a major
economic impact through
-

a better attractiveness for industry trials (including early proof-of-concept studies
and trials initiated by biotechnology and medical device SMEs)

-

a better attractiveness for EU funded clinical research projects

-

revenues generated by the development of innovative health products,

-

cost-containment due to large scale treatment strategy and head-to head
comparison trials, leading to evidence-based medical practices, and

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Acronyme du projet / Acronym:

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SCIENTIFIC SUBMISSION FORM B

 
-

optimization of treatments, leading to a decreased burden of health
expenditures in a healthier population.

It is also expected to foster the competitiveness of national clinical research in a
rapidly changing environment, as the competition is no longer between Universities or
Hospitals within the same country, but rather between Europe and other world regions.
Integration and coordination of clinical research infrastructures must therefore be achieved
both at the national and the pan-European levels – which is the main objective of this
program.

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Acronyme du projet / Acronym:

F-CRIN
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SCIENTIFIC SUBMISSION FORM B

 

2. CONTEXT: SCIENTIFIC ENVIRONMENT AND POSITIONING
OF THE INFRASTRUCTURE PROJECT

Clinical research refers to biomedical research performed on human participants, enabling
evidence-based medicine and representing a critical step in the generation of medical
knowledge, close to its application in humans. The stringent ethical and regulatory
framework, the requirement for high quality and credibility of the data and subsequent
analyses highlight the need for professional support to clinical research.
2-1. The development of clinical research infrastructure
The NIH developed in the 1970s a pioneering model for clinical research infrastructures
as hospital based facilities (general clinical research centers, gCRC). In France, the
adoption in 1988 of a very stringent legislation on clinical research (the Huriet law),
particularly for studies performed on healthy volunteers, resulted in three simultaneous
policies:
i) The national health insurance system (Assurance Maladie) has been funding clinical
research since 1993 through the Programme Hospitalier de Recherche Clinique (PHRC);
ii) In 1992, the Ministry of Health started creating clinical research offices (Délégation à la
Recherche Clinique, DRC) acting as public sponsors and coordinating clinical research in
each University Hospital, later becoming DRCI (for Innovation, 2006), and sharing
resources within 7 DIRC at the inter-regional level (Délégation Interrégionale à la
Recherche Clinique, 2006) (see chapter 3-2 for a maps of CHU and DIRC in France).
iii) This also led INSERM and University Hospital to jointly create, since 1992 and through
competitive calls, hospital-based clinical research facilities with specific beds, equipment,
and a professional staff, providing professional, high quality support to experimental
medicine and early phase clinical trials. This led to the progressive development of 54
Clinical Investigation Centres (CIC), most of them providing generic support to clinical
research (CIC-P), but some of them specializing in biotherapy (CIC-BT), in health
technology (CIC-IT), or in clinical epidemiology (CIC-EC)(see Chapter 3-2 for a map of
CICs in France).
iv) This has been complemented since the late 90s by the spontaneous creation of local
clinical trial units and/or data centers in several University Hospitals and cancer institutes.
Few of these units have presently reached a level of national/international expertise (at the
exception for example of cancer or AIDS), and a structured evaluation process has not
started yet in most University Hospitals.
2-2. French networks on the national and ESFRI roadmaps
In France, translational and early trials are conducted in Clinical Investigation Centres
(CIC). The CICs undergo national competitive evaluation every 4 year, as well as audits
controlling their quality assurance system and their GCP compliance. The CIC are
organized as a nationwide network1 coordinated by INSERM.
In University Hospitals, clinical research has been coordinated by DRCI since 1993. They
are in charge of promoting and selecting clinical research projects mostly phase 2 and 3
                                                                                                                         
1

www.inserm.fr/qu-est-ce-que-l-inserm/forces-de-la-recherche/centres-d-investigation-clinique-cic

8 /309

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Acronyme du projet / Acronym:

F-CRIN
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type trials. At first, DRCI belonged to informal networks, but later on they were formally
organized at the interregional level through DIRC. DIRC have allowed a first attempt to
merge means and competences, which can locally insufficient at a given site level. DRCI
have also played a part in the training of clinical research professionals.
The conception and management of large multicenter trials are often led by the nationwide cooperative groups that have developed in the main fields of research. These
cooperative groups are able to promote industrial trials; they work in cooperation with
DRCIs for the promotion of academic studies. The CIC network is listed on the national
roadmap for large research infrastructures2 (TGIR) together with the 7 DIRCs, and
represents the French component of the pan-European, ESFRI-roadmap3 clinical research
infrastructure (ECRIN4), whose pan-European coordination is also hosted by INSERM.
However, the National Strategy for Research and Innovation5 (SNRI) stresses the need for
upgrading this national clinical research infrastructure. Recent developments in the
national context offer a unique opportunity for substantial changes affecting clinical
research, whose supervision and support was previously split between the research and
the health sectors.
2-3. International benchmarking
There is a growing competition among countries to foster the competitiveness of national
clinical research. For this reason, many countries have massively invested in the
development or upgrading of their national clinical research infrastructure. In France, the
public sector and the pharmaceutical industry spend huge amounts of money in clinical
research, but France, who appeared as a pioneer in Europe in the 1990s, now has to
make its infrastructure more competitive in this changing context.
In addition, international networking has emerged to facilitate multinational cooperation in
clinical research in spite of the fragmentation of health and legislative systems, as access
to large patient populations is a critical factor for success. Efficient participation in such
multinational initiatives (France hosts the coordination of the pan-European distributed
infrastructure ECRIN) requires a better adaptation of the national clinical research
infrastructure to international standards and expectations.
Benchmarking of support structures in other countries helps define three levels of support
to clinical research:
a) Support to investigation: these structures support both academic and industrysponsored clinical research, with various models depending on the nature of the clinical
studies.
Support to experimental medicine and early phase trials:
These structures develop high-quality support to clinical studies requiring invasive
investigation, whatever the disease area. This is typically achieved through hospital-based
clinical research facilities with specific beds, staff and equipment. Derived from the NIH
                                                                                                                         
2

www.enseignementsup-recherche.gouv.fr/cid23165/une-nouvelle-feuille-de-route-pour-les-grandesinfrastructures-de-recherche-europeennes.html
3
http://ec.europa.eu/research/infrastructures/pdf/esfri/esfri_roadmap/roadmap_2008/esfri_roadmap_update_20
08.pdf#view=fit&pagemode=none
http://ec.europa.eu/research/infrastructures/pdf/esfri/esfri_roadmap/roadmap_2008/bms_report_2008_en.pdf#
view=fit&pagemode=none
4
www.ecrin.org
5
www.enseignementsup-recherche.gouv.fr/pid20797/la-strategie-nationale-de-recherche-et-d-innovation.html

9 /309

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Acronyme du projet / Acronym:

F-CRIN
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SCIENTIFIC SUBMISSION FORM B

 
gCRC model, the UK-CRF6 and the French CIC mostly correspond to this role, and
support both industry-sponsored and investigator-initiated studies.
Support to late phase clinical trials:
Trials requiring access to large populations of patients and less invasive investigation
(typically phase III-IV studies) take advantage of disease-oriented investigators networks
recruiting patients throughout the health system, from primary care through university
hospitals. Various models exist across the world – for instance the clinical research
networks (NIHR-CRN7) embedded into the national health services (NHS) in the UK, and
associated with a national coordination centre providing generic tools.
Interface for industry-sponsored trials:
Some countries have developed specific interfaces between industry sponsors and the
clinical research capacity. In France, for instance, both the main cooperative groups in
their specific fields and the CeNGEPS at a more global level act as an interface through
three main mechanisms: local support to patients recruitment, the development of common
tools for study management and contracting, and support to disease-oriented investigators
networks in areas of major industry investment
b) Support to study management: this is typically achieved by clinical trial units
(CTU), which are very well developed in the UK and in Scandinavian countries. Most CTUs
are located in universities rather than in hospitals, and specialize in a given medical area.
They focus on academic trials, providing support to study design and methodology, metaanalyses, randomization, biostatistics, adverse event reporting and study monitoring.
Some of them are linked to a professional data centre, using professional databases and
software for remote data entry.
c) Support to sponsors: academic institutions acting as sponsors may need
support for some of the sponsor’s tasks at the international level, including interaction with
ethics committees, interaction with competent authorities, insurance contracting, adverse
event reporting, monitoring. These structures are of particular importance in the
Scandinavian countries, where academic investigators also act as sponsors: in Denmark,
University Hospitals have developed GCP Units that endorse their sponsor’s duties.

                                                                                                                         
6
7

www.ukcrfnetwork.co.uk
www.crncc.nihr.ac.uk

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Investigator-driven clinical
research

Industry-sponsored clinical
research

Industry sponsors

Support to academic
sponsors

Data centres
Industry study management or CROs
Support to study management
Clinical trial units
Interface with industry sponsors
Recruitment, contracting, networks
Later phase :
Investigator networks

Support to
investigation

(CeNGEPS)LEEM

Early phase / experimental medicine :
Clinical research facilities

Models for public clinical research infrastructures

Of course various combinations exist, and interestingly some models offer multiple levels
support. This is illustrated by the German KKS8, able to provide local support to
investigation (including a sub-network for pediatric studies), also acting as a CTU providing
support to study management, and supporting Universities in their sponsor’s role.
2-4. Current situation in France
The current organization in France9 is quite heterogeneous and only partly covers the
expectations and needs of the clinical research community. University Hospitals, INSERM
and few disease-oriented structures (cancer, AIDS) plays this role at the regional and/or
national level, but overall, national support to large academic trials must be improved, and
a pan-European survey10 has pointed to the fragmentation and poor availability of
professional data management tools and data centers in France. As a consequence,
various structures have emerged over time (CIC, DRCI, DIRC, URC…) but there are gaps
and heterogeneity in competence (and sometimes overlaps), without appropriate and
consistent governance, funding, quality audits, or scientific and financial evaluation (see
Chapter 3-2: partners description, relevance and complementarities). There are also a
number of other structures involved in the support to clinical research activities, with
                                                                                                                         
8

www.kks-netzwerk.de
Demotes-Mainard J, Chêne G, Libersa C, Pignon JP : Clinical research infrastructures and networks in
France : report on the french ECRIN workshop. Thérapie, 60:183-199, 2005.
10
Kuchinke et al. Heterogeneity prevails: the state of clinical trial data management in Europe –results of a
survey of ECRIN centers. Trials 2010, 11:79.
9

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varying levels of maturity depending on the disease area, the most advanced and
developed research organization being in the fields of cancer and AIDS.
a) Sponsors: Public sponsors are rather well developed in France. University
Hospitals’ sponsor offices, hosted by DRCI, that now undergo scientific and technical
evaluation by AERES. The DRCI now share resources within 7 interregional structures
(DIRC), that also act as the target for an interface (CeNGEPS) between the industry and
the clinical research capacity. Some DRCI, particularly in Paris (APHP) have developed a
specific capacity for study management acting as clinical trial units (Unité de Recherche
Clinique, URC). Other major institutions have developed their own sponsor capacity at the
national level: INSERM (mostly for experimental medicine/ physiopathology), ANRS (for
AIDS studies), INCA (for cancer studies) and other academic institutions.
b) Clinical trials units and data centres: Although some initiatives bridge the gap
in restricted geographic (Paris with the URC system) or disease areas (cancer, AIDS) the
competence in support to study management (CTU) is uneven in France. Unlike in other
countries where CTUs are created based on competitive calls, undergo peer-review and
compete for funding based on scientific excellence, most of the equivalent structures in
France are created and funded by public sponsors as an extension of the sponsor office.
Such structures have not undergone regular evaluation yet, but should do so in the near
future by AERES. The capacity in data management is rather poor in France when
compared to neighboring countries (Germany, UK, Switzerland, Scandinavian countries),
with few professional softwares, databases, and professional teams reaching the critical
mass11.
c) Support to investigation: Local support has largely benefit to experimental
medicine and early phase studies because of the implementation of CICs in several
University-Hospitals, and a set off cancer or HIV vaccine early phase units, such structures
providing dedicated study personnel and investigation beds to help investigators.
Interestingly, in France, LEEM and ARIIS recently emphasized the importance for the
pharmaceutical industry to re-inforce in our country our capacities in this area, in
order to consolidate our position in early drug development phases, as other
countries might be intrinsically more competitive for Phase III programs because of costs
and patients’ availabilities. Coordinated actions to improve network activities and shared
competence is thus needed, and disease-orientated networks on the model of those
developed by ANRS and INCA, and attempts like the CIC disease-oriented networks are
needed for experimental medicine and early phase trials.
On the other hand, in spite of some exemplary initiatives (ANRS, INCa) and individual
efforts to set up University Hospital local facilities (URC, CIC-EC and others) the support
to large multicentric academic clinical trials remains under-developed and largely
fragmented in many fields in our country. This has limited the development of academicsponsored Phase III-type trials at the national level, and the leadership of our teams in
coordinating large international multicentric studies at the European level whereas the
expertise of French investigators and the quality of medical research are well recognized.
Cooperative groups are efficient tools for fostering the enrolment of patients in clinical
studies, and for structuring the clinical research capacity through the development and use
of common tools and procedures. University-Hospitals, INSERM, and Universities involved
in promoting and supporting such trials have each developed individual strategies. Various
initiatives have led for example to the set-up or support of disease-oriented investigators
                                                                                                                         
11

Kuchinke et al. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a
survey of ECRIN centres. Trials 2010, 11:79

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Acronyme du projet / Acronym:

F-CRIN
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SCIENTIFIC SUBMISSION FORM B

 
networks (including the recent CeNGEPS funding to investigators networks for industrysponsored trials, or the identification of disease-specific CIC networks). However, in most
instances neither systematic approach nor coordinated efforts or funding have been
obtained (except cancer through INCa, or ANRS for AIDS) and overall, most partners
confess that key technical facilities still remain insufficient to up-grade the French system
to the level of its European competitors in terms of networks, CTUs and data centers.
Based on this context, the F-CRIN project aims at bridging this gaps by:
1- gathering together all players in clinical research at the national level
2- offering a national hub able to accept through competitive calls clinical research
projects from early translational research up to large multicentre intervention,
prevention and epidemiological studies.

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Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

3. PROJECT MANAGEMENT

3-1. Management
a) Relevant experience of the project coordinator
Olivier Rascol, MD, PhD, born in 1958, is the F-CRIN project coordinator. He is Professor
of Clinical Pharmacology in the Toulouse University Hospital since 1993. He obtained his
MD in Neurology (Toulouse, 1985) and his PhD in Neurosciences (Paris, 1992). Dr Rascol
is running the Toulouse Clinical Investigation Centre (CIC9302) since 1994 (last evaluation
: A+) and chairs the national network of French CICs since 2008. He is running the
thematic CIC Network in Neurosciences since 2010 and is also part of the Research
Group on Motricity of INSERM UMR U825 (last evaluation : A+). Since 2007, he
coordinates the French Reference Center for Multiple System Atrophy (a rare atypical
parkinsonian syndrome).
As a clinical neuropharmacologist, Pr Rascol is acknowledged as one of the top world
leaders for the development and assessment of antiparkinsonian therapies. During the last
2 decades, he has been instrumental in designing and implementing early proof-of-concept
and Phase III clinical trials that brought from R&D to the market most recent
antiparkinsonian medications (ropinirole IR and ER, rasagiline, entacapone, pramipexole
ER). This was achieved via long-standing collaborations with international academic
research groups and large pharmaceutical companies in Europe and in the US. Pr Rascol
has published > 300 articles in international peer-reviewed scientific journals (NEJM,
Lancet, Lancet Neurol, Ann Neurol, Neurology, Arch Neurol, Brain, Mov Disorders…) and
his Factor H is 49. He has been or is currently at the editorial board of international
scientific journals (Lancet Neurol, Neurology, Eur J Neurol, Mov Disorders, J Neural
Transm, Evidence Medicine...) (The list of publications 2005-2010 is enclosed in Appendix
3).
. He has also exerted international responsibilities within several scientific societies: he
was Secretary of the Movement Disorders Society from 2006 to 2009, he is a member of
the WFN Research Group for PD and Related Disorders and will be the next chairman of
the European Movement Disorders EFNS/MDS-ES group. Pr Rascol organized the MDSPD Paris meeting in 2009 (>5000 participants).
Apart from this international scientific expertise, Pr Rascol has also largely participated
over the past 20 years in the implementation and functioning of most French structures
developed to support Clinical Research in France. He is therefore familiar with all
mechanisms and partners governing Clinical Research in this country, from their
background and achievements to their fragmentations and limitations. Indeed, Pr Rascol is
exerting or has exerted many responsibilities in Clinical Research for the different partners
of the F-CRIN project: for INSERM, he co-chaired the COSSEC from 2000 to 2004, he
coordinates the CIC 9302 since 1994, he chaired the evaluation group of CIC from 2006 to
2009, he is a member of the evaluation experts for the joint call for Clinical Transaltional
Research by Ministry of Health-INSERM, he chairs the CIC Neurosciences network since
2010 and the French national network of CIC since 2008; for University Hospitals, he
runs de Toulouse CIC from 1994, he is at the board of the Toulouse Délégation à la
Recherche Clinique et à l’Innovation (DRCI) since 2004 and at the board of the
Délégation Inter-Regionale à la Recherche Clinique (DIRC Sud-Ouest) since its creation in
2007; for the Ministry of Health, he is expert at the Programme de Recherche
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Hospitalière (PHRC) and is the PI of several national multi-centric PHRC programs; for
Universities, he is member of the Council of the Medical Faculty of Toulouse since 2004
and participates in several training programs (Master, University Diploma on Clinical
research); for AVIESAN, he is one of the experts of the Public Health ITMO; for the
Cengeps, he is a member of the Scientific Committee from its creation.
At the European level, Pr Rascol has served as an expert for EMEA and for the UK PD
Society. He has acted as an external international expert to assess the German KKS PD
network. He has run several WP of European PCRDs. As the current chair of the French
Neurosciences CIC network, he acts as the contact person of the ECRIN network for
clinical Neurosciences projects.
With such an experience in clinical research in France and abroad, combining both
an investigator-based as well as a sponsor-based perspective and having
participated in the functioning of many of the French infrastructures set-up in the
field, Pr Rascol has an in depth global view on the achievements, strengths and
challenges faced in 2010 by our Clinical Research system, including its diversity,
heterogeneity and insufficiencies. He also has a long experience of partnership with the
pharmaceutical companies who are and will remain major actors of the field. He is aware
of their own challenges and priorities, but he also knows the existence of converging
interests between public and private initiatives, and has demonstrated in the past within
the Toulouse CIC how feasible and beneficial such a partnership can be for simultaneous
high scientific valorizations and positive economical developments.
b) Coordination modalities
Coordination and organizational modalities, a proposed organization chart, modalities and
rules for use and access to the F-CRIN “hub”, training and communication aspects are all
developed in the 9 different work package (WP) of the following paragraph (See
Chapter 4: Technical and scientific description of the activities).
These key aspects represent the core of the first 24 months of the investments of the FCRIN project (phase I), bridging and bringing together in a unique collaborative joint
initiative the 3 key partners of Clinical Research in France, namely INSERM, the University
Hospitals and the Universities. Considering the diversity of participants, their past
implication and the importance of the stakes, the present program cannot propose at this
stage a finalized organization for this novel infrastructure. Common principles have been
agreed through high decision level meetings between the partners, and it is proposed that
the first 24 months of the F-CRIN project will be dedicated to finalizing these crucial issues,
with clear objectives and timely deliverables corresponding to specific work packages
(WP) run by the best possible experts in the field in France (see Chapter 4: technical and
scientific description of the activites).

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3-2. Collaboration organization
a) Partners description, relevance and complementarity
The partners of the F-CRIN project represent the key organizations involved in the
management, promotion and support of academic clinical research in France: INSERM,
University Hospitals and Universities. They are namely designated as INSERM,
Conférence des Directeurs des Hopitaux, Conférence des Présidents de CME,
Conférence des Doyens des Facultés de Médecine (the last 3 conférences being
coordinated within the « CNCR »), and the Conférence des Présidents d’Université.
Participant 1: INSERM (National Institute for Health and Medical Research): The
French National Institute of Health and Medical Research (Inserm) is a public scientific and
technological institute focusing entirely on human health. In 2008 Inserm took on the
responsibility for the strategic, scientific and operational coordination of biomedical
research. Ten thematic institutes (ITMO) were created in the light of this new coordination
role. From the outset, Institute has forged close partnerships with the other public and
private research establishments as well as hospitals to fulfill its missions. 80% of Inserm’s
318 research units are currently set up in university hospitals or cancer research centers.
Inserm plays a leading role in creating the European Research Area and boosts its
standing abroad through close partnerships (teams and partner laboratories abroad).
Lille

Inserm’s 315 Units
(01/01/2008)
Rouen

Amiens

Caen
Brest

IdF

Reims

Rennes
Angers
Nantes

Orléans
Tours

Poitiers

Strasbourg
Nancy

  Limoges

Dijon

Besançon

Clermont
Lyon
Ferrand
Grenoble
St
Etienne

Bordeaux
Toulouse

Marseille

Nice

Montpellier

Participant 2: The conference of the Presidents of the Medical Hospital committees
(CME) (Conférence des Présidents de Commission Médicale d’Etablissement )
The presidents of the CME of the 29 French University hospitals (CHU) are members of
the assembly representative of all practitioners working in University hospitals. This
assembly is in charge of practical training of health professionals. The assembly is a
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driving force for the promotion of Clinical Research in University hospitals and public
cancer centers.
Map of the French University Hospitals
(CHU for Centres Hospitaliers Universitaires)  

Participant 3: The conference of Hospitals Chief executive (Conférence des
Directeurs Généraux de CHU) : This assembly gathers Chief Executives of University
and Regional hospitals with the mission to improve patients care and hospitals efficiency
and to promote the assets of University hospitals. The assembly is a major interplay for the
Ministry of Health with respect of the implementation of Health policy in the University
hospitals, with special interest for the development of Clinical Research. This conference
interacts strongly and frequently with the other bodies described below.
Participant 4: The conference of the deans of Schools of Medicine (Conférence des
Doyens des Facultés de Médecine ): The assembly of the deans of the Faculties of
Medicine warrants the quality and progression of medical training in the French
universities. By promoting academic formation and medical research within these
universities, this body is also a driving force in quality of care.
CNCR (Comité National de Coordination de la Recherche) : CNCR is an entity
coordinating the efforts of the precedent conferences (CHU directors (Chief executives),
Faculty Deans and Presidents of CME) to make clinical research in University Hospitals
visible and coherent. It relies on 6 working parties organized in thematic networks (quality
promotion, trial security, harmonization of practices, evaluation, innovation, development).
Participant 5: Conférence des Présidents d’Université (CPU) : The CPU brings
together all types of French Universities (Universités Technologiques, Instituts Nationaux
Polytechniques, Ecoles Normales Supérieures et Grands Etablissements). The CPU
represents here all the Universities attached to the University hospitals. It represents and
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defends the interest of 109 higher education member institutions. With the law on the
independence of universities placing them at the heart of the research policy, they will also
be a key partner. In a context of profound change of the higher education and research
sector, the CPU has the role promoting the French university system and its values.

Other parties (non contracting): Apart from the 5 “official” partners of the F-CRIN project,
several other entities corresponding to academic and industrial major actors in the field are
directly concerned by the F-CRIN project. They all have officially been informed of the
project and have provided official support to the project.
 ARIIS (Alliance for Research and Innovation in Health Industries) is composed
of representatives of the French health industries (LEEM) dealing with research
and innovation. It has launch the 1st directory of R&D centers of pharmaceutical
companies, A platform for studies, deliberation and proposals (A PLEA FOR LIFE
SCIENCES) was drawn up under the auspices of the Scientific Board with the
participation of many parties. Its aim is to draw attention to the scale of the
challenges which concern the future of France and to the urgent need to respond
ambitiously. ARIIS recently emphasized the importance for the pharmaceutical
industry in France to up-grade and facilitate early phase studies (Phase I-II) in the
international competition of drug development.
 CeNGEPS (National Centre for management of trials on health products) is an
innovative model for support, through a tax collected from the industry, to the
interface between industry sponsors and the clinical research capacity. Its main
objective is to foster patients recruitment through specific staff, but it also supports
investigators networks and the development of common tools (study management
tool, costing template, support to contracting) to facilitate public-private
partnerships.
 ANRS (National Agency for Research on AIDS and Viral Hepatitis) is the leading
organization for research on the HIV/AIDS ad Hepatitis epidemics in France. It is a
funding body mobilizing teams in areas it deems priorities. ANRS sponsors clinical
trials and cohort studies, many of which have been milestones in improving the
treatment of people infected by HIV or viral hepatitis.
 INCa (National Cancer Institute) is a health and science agency dedicated to
cancerology. It operates on an interdisciplinary basis, with the aim of federating,
uniting and mobilising players and resources around joint projects. It provides
relevant information to the population, patients and healthcare professionals, and
ensures that there is a continuum between care and research. The Institute
launches calls for projects to support structures and fund innovative initiatives in
the fields of research, care, prevention, screening and patient support Aviesan
(Alliance for health and life science research) includes 8 main public institutions
with which universities and university hospitals are partnered. The main objectives
of Aviesan are to coordinate the strategic analysis, scientific programming and
operational implementation of life and health science research and to give a fresh
boost to translational research by speeding up the transfer of fundamental
knowledge to clinical application and to increase cross-disciplinarity. AVIESAN is
organized in thematic multi-organization institutes (ITMOs), the role of which is to
chair the strategic debates within their own scientific community.

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b) Complementarities and added value of the different partners
The association of the different partners and other parties within the F-CRIN project covers
most of the landscape of clinical research in France, from early translational steps to later
phases and larger studies (clinical trials or epidemiological approaches), from a private or
an academic perspective. Each one brings its history, its experience, its interests and have
accepted to work together for common goals that are crucial to improve the position of
France in the international competition.
The following section briefly summarizes the most illustrative examples of add-values
brought by the partners (or other parties) to the F-CRIN project:
INSERM
Inserm has more than 300 research Units, including the CICs (see below), providing a
unique potential for translational activities. Inserm has developed during the past a
respected experience in evaluation of research units and in running large national and
international collaborative research programs. Inserm also has experience in sponsoring
clinical research projects at the national level (Department of Clinical Research and
COSSEC) and at the European level (ECRIN)
University Hospitals
The 29 University hospitals have developed local and national experience in sponsoring
clinical trials via their “Delegations à la Recherche Clinique et à l’Innovation” (DRCI). DRCI
were recently formally organized at the interregional level through 7 DIRC. DIRC have
allowed a first attempt to mutualization means and competences, which can be locally
insufficient at a given site level. The 7 DIRC are listed on the national roadmap on
research infrastructures. The University Hospitals provide also most the largest access to
patients. Moreover, some of them have developed local clinical research facilities for
clinical research methodology and data centers (such as URCs at APHP). A specific
national grant from the Ministry of Health (PHRC) has been implemented to fund clinical
research trials in the University hospitals and a part of a special budget allocated to the
University Hospitals by the Ministry of Health (MERRI) is also dedicated to fund some
clinical research structures such as the CICs and DRCIs.
Universities
The recent law on the ‘Independence des Universités” reinforces the role of Universities in
Research in France. The French Universities also provide most of the training expertise in
fields relevant to clinical research, including methodology, GCP, Biostatisitcs,
Pharmacology…
ARIIS
ARIIS has a national and international view on worldwide R&D in the pharmaceutical
industry and supports nitiatives aiming at facilitating and developing Clinical Research in
France.
ANRS and INCa
Both disease-oriented agencies have been pioneer and successful in setting-up disease –
oriented clinical research infrastructures that can serve in many instances as models for FCRIN goals.
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c) Successful joint initiatives already implemented in collaboration between 2
F-CRIN partners to support clinical research in France:
> Clinical Investigation Centers (INSERM & University hospitals)
Since 1992, in partnership with different University Hospitals, INSERM created Clinical
Investigation Centers, to facilitate the transfer of knowledge and investigations from
experimental labs to patients. CIC offer high quality clinical investigations facilities. There
are currently 54 CICs located in 20/29 University Hospitals in France: (a) 27 poly-thematic
CICs (P), which act as hospital-based clinical research facilities providing generic support
to experimental medicine and early phase investigation at the local level, with specific
beds, equipment and staff; (b) 10 biotherapy CICs (BT), which focus on trials for gene and
cellular therapies, coupled to facilities for cell and vector processing (c) 8 technology
innovation CICs (IT), which are translational research centers developing both the
preclinical and clinical proof of concept in selected areas of health technology (from lasers
through tissue engineering) and (d) 9 clinical epidemiology CICs (EC), which are designed
for support to epidemiological studies, performed outside the hospital. (The list of
publications 2005-2010 is enclosed in Appendix 4)
Since 2003, INSERM in coordination with University Hospitals, has organized the French
CICs into both a national CIC network and disease-oriented networks (cardiovascular,
neurosciences,
paediatrics,
thrombosis,
diabetes
and
metabolic
diseases,
gastrology/enterology/hepatology, technologicals innovations, etc.). This organization
strengthens the collaboration of CICs working on the same themes, fosters the set-up of
joint research projects and ensures the harmonization of good clinical and laboratory
practices.
The following map illustrates the distribution of the French CIC network. As mentioned
above, the CIC network is as the French component of the ESFRI-roadmap ECRIN
infrastructure, and is listed on research infrastructures. Each CIC is created after
competitive evaluation as a joint venture between INSERM and a University Hospital,
undergoes competitive scientific and financial peer-review, as well as system quality and
GCP audits.

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> Grant applications (INSERM & Ministry of Health)
Since 2006, INSERM and the Ministry of Health have developed a common grant
application to promote Clinical Translational studies involving pre-clinical research groups,
clinicians and CICs. This program has been funded 150 projects up to now.
> Training
Each participant of the F-CRIN project has its own training program for clinical research.
Recently, joint initiatives have been developed, such as for example the Inserm a Summer
School between INSERM and ARIIS. The Cengeps also recently proposed teaching
initiatives with the University Hospitals.
> Recruiting patients in clinical trials (Cengeps & DIRC)
The Cengeps has developed within the last few years a program to provide financial
support to improve French competitiveness in recruiting patients in trials sponsored by the
industry. Several millions euro have been allocated to the 7 DIRCs to drive initiatives
enhancing French competitiveness in this area.
> Networks (INSERM & Cengeps)
Another of the Cengeps efforts to support recruiting patients in clinical trials sponsored by
the industry is to fund investigators disease-oriented investigator networks, and several
CIC networks have benefited from this type of grant.
All these examples deliver clear signals that the different partners are convinced that
collaborative efforts are mandatory to overcome the complex historical fragmentation of
the current French system and that a global collaborative and complementary approach is
mandatory to bridge the gaps and offer common answers to key unmet needs. The
present call “Investments for the Future” therefore represents a unique and timely
opportunity to provide the complementary funding to invest into missing or insufficient key
nodes of the system and provide a global coordination approach through the F-CRIN
project.

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4. TECHNICAL AND SCIENTIFIC DESCRIPTION OF THE ACTIVITIES

4-1. General Overview
As previously emphasized, the current fragmentation and heterogeneity of partners
and structures in Clinical Research represent an important problem of the French
system. Improvement in the governance of the F-CRIN clinical research infrastructure
aims at promoting coordination and integration between the partners. Such a coordination
and integration at the national level will strengthen its impact on the structuring of clinical
research at the pan-European level through ECRIN12 and HOPE13, and will enable French
research groups to more easily initiate, or participate in multi-sites multinational studies.
As a consequence, it now appears critical to further develop the French clinical research
capacities to bring together the main partners active in the field in order to cover in a
cooperative manner the whole spectrum of competences required to meet the
expectations of academic and industry users, particularly through the reinforcement and
the development of structures with appropriate and consistent expertise, governance,
funding, quality audits, scientific and financial evaluation. The F-CRIN project is therefore a
collective initiative developed by the 3 key academic French partners involved in
Clinical Research in France (INSERM, University Hospitals and Universities). Such a
project meets the expectations of the pharmaceutical industry and is supported by its
French representative entities (LEEM and ARIIS) (see accompanying letter from
LEEM/ARIIS).
The objective of the F-CRIN project is to improve in a collaborative manner their
capacity to implement and manage clinical studies, from early translational aspects
(seen as a major opportunity in France for the pharmaceutical industry) to large
multicentric clinical/epidemiological trials (seen as a field left behind the time by many
academic investigators and sponsors), in order to strength French competitiveness in
these areas at the international level. To achieve these goals, the F-CRIN infrastructure
will focus its efforts into 2 types of investments and 2 phases:
(1) the first investment will be dedicated to implementing or up-grading key clinical
research facilities (phase I) (namely disease-orientated clinical Networks, Trial Units
(CTUs) and Data Centres) that are still insufficiently developed in many fields in France.
Specifications and calls for such facilities will be developed during the first 24 months of
the project
(2) the second type of investment will be dedicated to setting-up a coordinated and
transparent access to and use of such the F-CRIN infrastructure (“Hub”) by private
and public sponsors and investigators. The first 24 months of the project will be
dedicated to define governance, coordination of services and “hub” access to the facilities
and to develop common procedures including quality assurance, study management,
pharmacovigilance, monitoring, auditing, etc… (phase I)

                                                                                                                         
12

Demotes-Mainard J , Ohmann C.: European Clinical Research Infrastructures Network : promoting harmonisation
and quality in European clinical research. Lancet, 365 :107-8, 2005
13
European Hospital and Healthcare Federation, www.hope.be

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Once F-CRIN established, the last 3 years of this investment (phase II) will be dedicated
to practical implementation of the first clinical research studies in order to test,
improve and demonstrate the efficiency of the F-CRIN infrastrucutre before allowing it to
live its own life .
At the end of this 5-year time, F-CRIN costs will be covered by the resources generated
through the services it provides to the projects funded by national or international
academic grants or industrial budgets.
This new “hub” infrastructure will be managed by the management board responsible for
the coordination of F-CRIN activities, working together with the governance council
representative of the different entities involved as partners in the F-CRIN. The Executive
Unit will assist the Management Board and will be composed of an executive manager
assisted by project managers and assistants to implement the different phases of the
project. An overall procedure for the calls for application of clinical studies will be
determined, with an agreement on how the specification will be translated into a call and
on the criteria for eligibility and acceptance and on the final decision-making process. To
avoid duplication of scientific evaluation, an adoption process should be organized for
protocols already peer-reviewed at the national or European levels. In addition to the
scientific assessment, the evaluation of the feasibility and the financial robustness of the
project should be carefully considered.

4-2. Presentation of the different Work Packages (WP) of the F-CRIN program
The F-CRIN program, as described in the present project, is composed of 9 strongly
interdependent WP:
- WP1: Governance and management
- WP2: Evaluation
- WP3: Coordination of services and access to infrastructure
- WP4: Development of common tools
- WP5: Education and communication
- WP6: Investigational networks
- WP7: Clinical Trial Units
- WP8: Data Centers
- WP9: Europe and connection to ECRIN
This presentation summarizes a unique collective national approach in this field in France
in order to bring closer different aspects of the French clinical research system. Each WP
is run by a limited number of experts under the leadership of a WP leader. All WP experts
and each WP leader have been appointed by mutual agreement between the different
partners. They have been chosen because of (a) their acknowledged national experience
and complementary competences in the domains corresponding to their WP, (b) an
affiliation that guarantees an overall balanced representation of each of the partner, (c)
their input in the elaboration of the objectives, tasks, deliverable and budgets listed in each

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of the WP and (d) their endorsement of the responsibilities related to their WP and to the
global project.
Overall, and as previously mentioned, F-CRIN proposes two different types of investments
covered by the 9 WPs:
A first type of investment is centered on the definition, implementation and functioning of a
coordinated “hub” infrastructure, including governance, management, common tools
and know-how shared between the partners (first two years ; phase I) that will be
developed, tested and improved during the second part of the program of the program (last
3 years ; phase II). WP1 will manage this program and implement the governance for the
national clinical research infrastructure, whereas WP2 will define its evaluation from the
scientific, technical and quality assurance perspective, and WP3 will define a procedure for
a hub and coordinated services. In parallel, WP4 will develop common tools and
procedures for QA, study management, pharmacovigilance, monitoring, and interface with
the industry, and will develop and maintain regulatory, ethical and GCP know-how. WP5
will manage training and educational aspects.
A second type of investment is centered on the specifications for the creation/upgrading of structures supporting investigation, study management and data management
in large-scale clinical trials (less than a dozen nationwide disease-oriented investigator
networks (WP6), a restricted number (half a dozen) of disease-oriented clinical trial
units selected on scientific excellence and reaching the critical size (WP7), and a few (3 to
5) professional data centres providing high quality services based on leading-edge
technology (WP8). These F-CRIN structures will be selected on the basis of competitive
calls in collaboration with WP2
These investments will enable efficient connection of the French clinical research
infrastructure to the pan-European infrastructure ECRIN (WP9), structuring a clinical
research capacity best adapted for large-scale trials and multinational collaboration, and
fostering the national participation in multinational clinical trials now funded by the FP7.

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WP1
Duration

GOVERNANCE AND MANAGEMENT
60 months

Start date

WP leader

O. Rascol, N. Ifrah

WP Task experts

B. Schlemmer, Y Morice,
G. Bréart / C. Lévy-Marchal

Personnel

384 person-months

Operation costs

500K€

Month 1

The objective of this work package consists of:
a - performing the overall management of the program and
b - defining lasting governance for the national clinical research infrastructure
WP1 leaders and experts are: Pr O. Rascol, coordinator of the F-CRIN project, Pr N Ifrah,
President of the CNCR, Pr Schlemmer, Dean of the Faculty of Medicine of the Paris VII
University, Mr Y Morice, Chief Executive of the Angers University Hospital, Pr G Bréart,
Director of the AVIESAN ITMO on Public Health , Dr C Levy-Marchal, Coordinator of the
Department of Clinical Research at INSERM.
Task 1a - Management of the project

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The Governance and functioning of the F-CRIN infrastructure will be carried by the
following bodies:
-

-

-

-

The Governance Council will represent the partners of the project (INSERM,
Conférence des Présidents de CME, Conférence des Directeurs de CHU,
Conférence des Doyens allied in the CNCR and the Conférence des Presidents
d’Universités).The governance council will be the body where the partners make
collective decisions to be implemented by the Management Board.
The Management Board includes the Coordinator of the project responsible for
the administration of the structure and the implementation of the WP program (Pr
Rascol) and 3 other members: WP1 co-leader for governance issues (Pr N Ifrah),
WP3 leader for coordination of services and access to the infrastructure (Mr R
Fieve) and WP2 co-leader for evaluation (Dr C Levy-Marchal). The management
board will be responsible of the management of the structure and implementation
of the WP program.
The Steering Committee comprises the Management Board and all the WP
leaders. It will supervise (every 3 months) the management of the different aspects
of the project and the coordination of activities between the different WP. It will
propose for approval the decision-making process for the competitive calls for the
networks, clinical trial units, and data centres to the Governance Council. It will
define the governance for the selected and supported networks, CTUs and data
centers.
The General Assembly is composed of all the actors of the program, including
task experts. It will meet at least one a month.
The External Advisory Board consists of national (AERES, INCa…) and
international leaders of the scientific community, of the pharmaceutical industry
(ARIIS, LEEM), and of other representatives of Clinical Research or Biobank
networks for example… This External Advisory Board will meet once a year with
the Management Board to promote interactions and novel initiatives.

The project coordinator and the management board will be supported in the daily
management of the project during the 5 years of the project by a core Executive Unit,
composed of an Executive Manager, a Project manager and two Assistants. This team
will ensure timely release of deliverables, proper management of the budget, coordination
of the various work packages and tasks, organization of meetings, and communication
with users, patients associations, and citizens through meetings, documents, and a
website including a directory of clinical research infrastructures. At the end of month 24,
four project managers issued from WP 3, 4, 6, 7 and 8 will join the Executive Unit once the
task dedicated to these WP (defining and developing the modalities of coordination and
access to the “hub” services, developed common procedures and tools for their
implementation, specification and call for networks, CTUs and data center) will have been
accomplished. During this second phase of the project (month 24 to 60), they will allow the
F-CRIN infrastructure to function practically for the first 3 years (see WP3), up to the point
when its full development will allow self-sufficient functioning.
Task 1b - Governance of the national infrastructure, during and beyond the project
A major goal of this program consists of linking or integrating different national clinical
research capacities on the model of a simplified “hub” through development and
implementation of coordinated services in order to offer an easy and transparent access to

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
the infrastructure for the investigators and sponsors. As mentioned above, lessons can be
derived from various models including the UK-CRC14.
The newly created facilities infrastructure will be supervised by the partners of F-CRIN
(Governance Council). Initially, for legal administrative reasons, INSERM might serve as
the single and temporary contractor, until a new legal entity representative of all partners is
set-up.
Governance will have to define the rights and obligations between parties of the distributed
infrastructure (hosted by various institutions), the minimum requirements regarding the QA
system, the costing and contracting templates, and the capacity for each structure to
deliver services. It will also define the functional links with ECRIN in the provision of
services to multinational studies. It will define the modalities for the connection to ECRIN
and HOPE and the procedure for contribution to the provision of services to multinational
ECRIN-supported studies.

DELIVERABLES
> Implementation of the legal infrastructure

M 12

> Specification for the governance structure

M12

> Implementation of a Website

M12

> Annual reports on the project management

M12 to M60

> Annual reports on communication with users, patients, citizens

M12 to M60

> Implementation of the governance structure

M18

BUDGET
Personnel:

240 person-months for the coordination during the 5 years of the project
- A full-time executive manager
- A full time project manager
- 2 full-time assistants
144 person-months for the operational functioning of the project during
phase II (4 project managers from WP3, 4, 6, 7, 8)

Operation costs: 500k€
- Office facilities (20k€/yr)
- Travels (20k€/yr)
- Meetings (20k€/yr),
- Communication (10k€/yr)
- Website (20k€/yr)
- Miscellaneous operations (10k€/yr)
                                                                                                                         
14

http://www.ukcrc.org

27 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
WP2
Duration

EVALUATION
60 months

Start date

WP leader

C. Thuillez

Task leaders

C. Lévy Marchal, D. Delmotte

Personnel

60 person-months

Operation costs

670K€

Month 1

The objective of this work package consists of defining a consistent strategy on how to
evaluate the elements of the clinical research infrastructure, for their creation and
subsequent evaluations:
a - Scientific and technical peer-review for the competitive calls,
b - Subsequent post-hoc scientific evaluation of the created structures every 4th
year by AERES
c - GCP and quality audits
d- Satisfaction of users (investigators/sponsors)
The leader of WP2 is Pr C Thuillez, Dean of the medical School of the Rouen University.
Mr D Delmotte, is Chief Executive of the Lille University Hospital, Dr C Levy-Marchal is
Director of the Department of Clinical Research at INSERM.
Task 2a - Modalities for the peer-review of the competitive calls
This task will define the overall procedure for the calls for application, with an agreement
on how the specification will be translated into a call, and on the criteria for eligibility and
acceptance and on the final decision-making process.
Briefly, the process will include
 a single international Scientific Board responsible for the selection of the projects of
infrastructure (WP 6, 7, 8)
 a panel of international experts for the peer-review of the projects submitted. Peerreview will evaluate the scientific approach from a disease-specific perspective as
well as the technical expertise and know-how of the projects. The choice of the
experts will be made in agreement with the Thematic Institutes of AVIESAN15 and
university hospitals (CHU).

                                                                                                                         
15

AVIESAN / Alliance pour les Sciences de la Vie et de la Santé

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
Task 2b - Modalities for the post-hoc evaluation by AERES.
The specification for the AERES post-hoc scientific evaluation should be coordinated with
the criteria for the selection of projects.
National and scientific evaluation of clinical research by AERES is being implemented in
2011, beginning with the CIC and extending a year later to the clinical research and the
infrastructures (DRCI, DIRC, local CTU … ) in the university hospitals (CHU). Based on
this experience and on the criteria of the calls, the various infrastructures created by the
various calls will be scientifically evaluated every 4 years.
Task 2c - Modalities for quality and GCP audits
This task will define the modalities for cross-auditing in line with the ECRIN policy, .
The aim is to evaluate and to improve the adequacy of the various infrastructures created
by the different calls with GCP and with the QA requirements developed by WP4, Task a.
Taking advantage of the work already done within the CIC network and other partners,
regular cross-auditing performed by both internal and external auditors, namely colleagues
from other European countries through ECRIN
Task 2d - For the assessment of the users’ satisfaction
Specific audits will be organized by external operators to test whether the services
provided by F-CRIN meet the expectations of its users.
DELIVERABLES
> Composition of the scientific board

M6

> Specification for the peer-review procedure for competitive calls
for the creation of the infrastructures

M12

> Specification for regular scientific evaluation by AERES

M24

> Specification for GCP and quality audits

M24

> Implementation of evaluations and audits

M24 to M60

BUDGET
Personnel:

60 person-months
- 1FTE for GCP and quality audits

Operation costs: 670K€
- International benchmarking (10k€/5 yr)
- Costs for evaluation of the competitive calls and meetings of the scientific
boards (60k€/5yr)
- Cost of AERES evaluation (100k€/5 yr)
- Cost of GCP audits (500k€/3 yr)

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

WP3
Duration

COORDINATION OF SERVICES, ONE-STOP SHOP ACCESS
60 months

Start date

WP leader

R. Fievé

Task leaders

O. Launay, E. Devilliers, V. Diebolt

Personnel

84 person-months

Operation costs

30K€

Month 1

The objectives of this work package consist of defining:
a - the modalities for the coordination of services at the national level
b - the modalities for the “hub” access to the infrastructure at the national level
Both objectives address a key issue in the program, as innovative solutions for better
coordination and facilitated access will result in a major improvement in the efficiency and
cost-effectiveness of the clinical research system in France. WP3 will have to achieve
these objectives during the first phase of he project (24 months)
WP3 leader is Mr Régis FIEVE, Director of Research (DRCI) at the Lille University
hospital. Mrs Elisabeth DEVILLIERS is Director of Quality and Research at the University
Hospital of Dijon, Mrs Odile GELPI is Director of Research (DRCI) at the University
Hospital of Dijon, Dr Odile LAUNAY is Associate Professor of Infectiology, Coordinator of
the CIC of Paris-Cochin, Mr V Diebolt is Director of Cengeps.

Task 3a - Coordination of services and administrative procedures
Provision of both coordinated services and administrative support at the national level is a
key facilitation for investigators and sponsors for multicentre national or pan-European
studies. Services will be accessible through the national F-CRIN coordinating “hub”
facilities, making advantage of the pre-existing structures (University Hospitals DRCI,
INSERM, CIC, DIRC …). This activity will take advantage of the work in progress for
example with the CeNGEPS or the CNCR. This coordination will be supervised by a group
of service coordinators in charge of identifying the problems, drawbacks and bottlenecks,
and proposing appropriate solutions at the organizational, management and governance
levels. This task will also identify the activities required to sponsor multinational clinical
trials and the current sponsors able to take over these activities in relationship with ECRIN.

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
Task 3b - Hub access, technical and scientific evaluation and support to
investigators and sponsors
In order to facilitate national multicentre, or multinational clinical studies, the national
infrastructure will offer an integrated access to all services of the F-CRIN research
infrastructure.
Briefly, 2 different situations can be envisioned:
-

Potential user (investigator or sponsor) approaching F-CRIN at a very early stage
of the project in order to conceive and build up the protocol

-

Potential user (investigator or sponsor) approaching F-CRIN with an already
available protocol and asking for operational support

In both instances, a technical and scientific evaluation will be performed for relevance and
feasibility, including budgetary plans. Instead of having a single scientific board in charge
of the assessment of all the projects submitted, the best appropriate solution is to provide
national access through disease-oriented scientific boards, each of them being linked to a
disease-oriented network and when relevant to a disease-oriented clinical trial unit. These
scientific boards will be composed of national and international experts, and will ask for
external peer-review by an international expert panel in connection with the corresponding
ITMO of AVIESAN. This evaluation will also benefit from the technical assessment by the
F-CRIN Executive Unit (see WP1). To avoid duplication of scientific evaluation, an
adoption process will be organized for protocols already peer-reviewed at the national or
European levels.
Once approved, F-CRIN will direct the clinical studies to the appropriate facilities (CTUs,
Data centers and Networks when relevant) and the Executive Unit will follow-up the
implementation and operational aspects of the study.
This WP will also define the costs that will be charged for each of the services provided by
the infrastructure to sponsors and investigators, considering whether they are private or
academic.

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
DELIVERABLES
> Specification for the coordination of hub services

M6

> Specification for policy and criteria for the single access to the "hub"

M24

> Procedure for nomination of the disease-oriented scientific boards

M18

> Creation of the disease-oriented scientific boards

M24

> Implementation of the coordinated services and of the “hub”

M24

BUDGET
Personnel:

84 person-months
- 3.5 FTE shared between INSERM, CNCR, CPU, INCa and ANRS for the
service coordinators during the first 24 months of the project. One of these
service coordinators will then join the Executive Unit (WP1) to provide
coordinated services through single access during the last 3 years of the
project (Month 24 to 60).

Operation costs:

30K€

- Meetings: 30k€

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APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

WP4
Duration

DEVELOPMENT OF COMMON TOOLS
60 months

Start date

Month 1

WP leader

C. Libersa

Task leaders

V. Journot, D. Bertram, V. Plattner, V. Diebolt

Personnel

84 person-months

Operations costs

1040K€

The objectives of this WP consist of developing common procedures and tools for their
implementation as nationwide standards in line, as far as possible, with the procedures
and tools developed and implemented at the European level through ECRIN. This WP will
not ‘reinvent the wheel’, but will take advantage of existing initiatives to select and adapt
the best adapted tools and procedures and spread the best practices. These common
tools and criteria will be used as criteria for the competitive calls for the creation/upgrade of
networks, clinical trials units and data centres.
WP4 is led by Professor C Libersa, Professor of Clinical Pharmacology at the University of
Lille and Coordinator of the CIC of Lille, Mrs V Journot is Biostatistician at the CIC-EC of
Bordeaux, Mrs D Bertram is a pharmacist in charge of the pharmacovigilance of the DRCI
of the Lyon University Hospital, Dr V Plattner works at the DRCI of the Lyon CHU, and Mr
V Diebolt is Director of Cengeps.
WP4 is split into 7 tasks:
Task 4a - Quality assurance
Taking advantage of the work already done within the CIC network and other partners, this
task will consist of defining the QA requirements for the various components of the clinical
research infrastructures, as well as the cost-effective tools implemented to ensure
compliance with the QA policy (self assessment, audits, certification, accreditation, with
links with task 2c). A critical issue will be to align this national QA policy with the ECRIN
requirements for multinational studies.
The ICH-GCP defines quality assurance and quality assurance has to be reinforced by
Quality control.
The ICH GCP are benchmarks dedicated to research on medicines for human use. Given
the wide variety of research sponsored by academic sponsors, it is mandatory to have a

33 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
Quality Assurance system for all kind of researches, not only those on drugs. To date,
there is no reference enforceable in France or in the European Union for other clinical
researches. Therefore it seems essential to work on Quality Assurance for all kind of
research, and fit the Quality Assurance system. That's why, since 2007, a working group,
issued from the CNCR gathering the 7 DIRC from 20 CHU (DRCI representatives) works
on the quality of academic sponsoring with the following objectives:
- To establish Quality Assurance for all types of clinical researches adapted to the
nature of the trial.
- To harmonize procedures to conduct multicentric academic clinical trials.
The objective of the group is to find a consensus on a basic set of standard operating
procedures for all types of researches and of the processes according to the follow up of
the trial (before the beginning, during and at the end of the trial). The group's work has
focused on the harmonization on common rules for audits of informed consents and
Monitoring procedures adapted to the different national studies with a future extension to
European management and will extend the project to the other procedures
Task 4b – Study management .
Development of a national study management tool for academic clinical research, in close
cooperation with the tool currently being developed (SIGREC) and of common costing and
contracting template, adapting to academic trials the LEEM-FHF initiative (cf task 3a).
This web application SIGREC has been developed by the Lille University Hospital allowing
exportation and import in (or from) other databases by the sponsors to have access to the
identification of clinical trials and to the progress of the inclusions in clinical trials.
In complement of this basic software various softwares have been developed for
pharmaceutical firms or academic institution (eg Inserm) to allow diary follow up of the trial
in terms of study data, patient visits management, study supply, CRFs and DCFs tracking,
SDVs tracking, files management, recruitment plan follow up, sub-contractors
management, study material follow up, alerts, queries editions, specific reports definition,
graphic production, study cost management, management of patient/center data
This framework makes mandatory development of common export formats with secured
incrementation.
Task 4c – Pharmacovigilance
The objective of this task is of the specification for certification of pharmacovigilance /
adverse event reporting for academic clinical research, to be included in the criteria for the
call for the creation / certification of CTUs.
In 2001, the Clinical Trial (CT) directive (2001/20/EC) deeply reinforced the responsibilities
of the sponsor regarding pharmacovigilance for clinical trials on medicinal products mainly
trough the implementation of the European phamacovigilance database (Eudravigilance)
and of the annual safety reports. An academic clinical trials safety working group (REVISE:
groupe de REflexion sur la VIgilance et la Sécurité des Essais) was created in 2007 on
behalf of the French Hospital Federation (FHF) and of the French Academic Sponsor

34 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
Coordination (CPI). REVISE gathers more than 80% of the French University Hospitals’
safety clinical trials departments and the majority of French non-commercial sponsors.
This French academic working group includes over 40 stakeholders.
Until now, this group has established guidelines, common procedures, common material
for training and education, common costing and contracting templates for
pharmacovigilance. This group had also organised MedDRA training sessions (≈ 60
persons attended).
Task 4d - Monitoring
The objectives of this task are to facilitate the implementation of the risk-based approach in
monitoring activities, in line with the ECRIN strategy, the OECD recommendations, and the
European guidelines currently being developed for the revision of the CT Directive to be
included in the criteria for creation / certification of CTUs.
Task 4e – Regulation, GCP, ethics.
The objective of this task is to develop a comprehensive and permanently updated
database on regulatory and ethical requirements. This will result in a user-friendly erepository both in French and English language, developed in cooperation with AFSSaPS,
and coordinated with the regulatory database and repository developed by ECRIN (there
are some existing models16, but the tool should be easy to use for national and
international users).
Task 4f – Interface with industry / CeNGEPS
The objective of this task is to develop common strategy for the development/up-grading of
disease-oriented investigation networks, for the co-development of costing, contracting,
and study management tools as well as information and communication targeting national
and international industry partners (medicines, biotechnology, medical devices), and with
PPP funding sources (bio-clusters (pôles de compétitivité), IMI).
Task 4g – Interface with BRC network:
Clinical trials generate numerous biological samples which need to be manage in respect
with strong procedures of conditioning and preservation.
The French biobanks and BRCs infrastructure have undertaken a project (project
BIOBANQUES) to increase resources level of coordination and efficiency of French
collection of biological, by setting up a sustainable infrastructure that will provide new
services, better access for users from public and private sector, develop public private
partnership and interface with the pan European infrastructure BBMRI and
EMBARC/MIRRI.
The interface between F-CRIN and project BIOBANQUES will be mandatory to contribute
to increase the scientific excellence and efficacy of French research in the biomedical
                                                                                                                         
16

www.ct-toolkit.ac.uk

35 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
sciences as well as expand and secure competitiveness of European research and
industry in a global context and attract back investments in pharmaceutical,

DELIVERABLES
> Specification for tasks 4-a to 4-f

M18

> First version of the study management tool

M24

> Update and follow-up of each task specification

M18 to M60

> Information and communication, strategy and implementation

M6 to M60

DELIVERABLES IN RELATION WITH BIOBANQUES
> Develop a “hub” access procedure to prioritize requests to biological resources and
associated data
M12.
> Implemented interoperability of research databases

M24

> Accrue sample and data exchange and encourage large scale distributed research
projects
M12 to M60
> Harmonize cost assessment to resources, associated data and access to services and
expertise
M12 to M24

BUDGET
Personnel:

84 person-months
-1 FTE for coordination and animation of the different tasks for the first 24
months of the project
- 1 FTE for each task for the 24 first months of the project
- I.5 FTE of this group will then join the Executive Unit (WP1) in order to
provide coordinated services through single access during the last 3 years
of the project (Month 24 to 60).

Operation costs:

1040k€

- Meetings (20k€/yr)
- Travels (20k€/2yr for each task)
- External services (legal advices, informatics contracting, miscellaneous)
(800K€/2yrs)

36 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

WP5
Duration

TRAINING AND COMMUNICATION
60 months

Start date

WP leader

B. Fallissard

Task leaders

B. Kassaï, A. Sommet

Personnel

36 person-months

Operations costs

540K€

Month 1

Objectives: To improve the level of knowledge and expertise of all the professionals
involved in clinical research. F-CRIN will therefore make an inventory of all available
trainings in the field, with a homogeneous and synthetic description of their content. It will
then identify nees and gaps and will develop a comprehensive education program taking
advantages of existing local and national programs.
B Fallissard is Professor of Biostatistics in the University of Paris and runs an INSERM
Research Unit in Public health. B KassaÏ is Associate Professor of Biostatistics at the
University of Lyon and works with the CIC of the Univesity Hospital of Lyon. A Sommet is
Associate Professor of Pharmacology in the University of Toulouse.
In France, there are at the moment a large number of courses dedicated to clinical
research in general and clinical trials in particular. These courses are offered by
professionals from very different fields: private company providing training for
professionals from the pharmaceutical industry; ad hoc sessions organized occasionally by
the pharmaceutical industry for interns or young hospital physicians; INSERM workshops;
academic courses offered by professors in pharmacology, therapeutics, biostatistics; these
course can be provided by Medical schools, schools of Pharmacy, Faculty of Science; etc.

Educational initiatives are largely fragmented in our country, and it is therefore crucial to
make an inventory of all available trainings in the field, with a homogeneous and synthetic
description of their content. More precisely the objective is to allow all interested
professionals to know where and who should be contacted in order to answer to a specific
need. Such an inventory will also be useful to identify possible unmet needs and thus to
develop new courses.
Based on such an inventory, a global offer of training will become possible to cover all the
logistical constraints of clinical research from ethical and regulatory issues to the

37 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
management of multicenter studies including the management of biological collection. This
approach will be helpful for people from everywhere in France, and will encourage
initiatives across universities under the management of a national committee. The program
will encompass the different types of expertise and jobs developed around clinical
research and will contribute to improve professionalization of these fields in France.
To implement the present educational program, a close collaboration will therefore be
developed between the F-CRIN partners, including Universities, INSERM, CNCR, and also
other parties that have already contributed to this field, like for example ARIIS or
CeNGEPS.
A dedicated website will be the ideal support to gather this information. Progressively, this
site will also propose written and multimedia (e-learning) documents so that training will be
available “à la carte” without any time and travel constraints. These documents will be
possibly criticized thanks to a series of strictly moderated forums.

DELIVERABLES
> Inventory of available courses

M12

> Web site design (in collaboration with WP1)

M12

> Collection of available written and multimedia material,
> Harmonization/dissemination of collaborative formation and diploma

M12 to M60

> Videotape recording of courses, development of e-learning

M12 to M60

BUDGET
Personnel:

36 person-months
- “State of the Art” procedure and preparation of formation harmonization –
0.5 FTE for the first 12 months
- Management of the task work, management of national pedagogic
committee, dissemination of information relative to clinical research
formation – 0.5 FTE for 5 years.

Operation costs:
540K€
- Meeting (20K€/5yr)
- Dissemination process (20K€/5yr)
- External services (workshops, e-learning…) (500K€/ 5 yr)

38 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

WP6
Duration

INVESTIGATOR NETWORKS
60 months

Start date

WP leader

F. Zannad

Task leaders

G. Salles, B. François

Personnel

24 person-months

Investment costs

5M€

Operations costs

50K€

Month 1

The objective of this work package is to launch calls for the creation / upgrade, after
defining the specifications, of large and high quality, non profit, clinical research
investigator networks. This objective includes upgrading and adaptation of existing
networks, integration and mergers leading to single national networks in a given disease
area, avoiding duplication, and reducing the fragmentation by the possibility of sharing
common tools. The total amount of supported networks is expected to be about 10 to 15,
mostly disease-oriented networks.
This WP has Pr F Zannad as WP leader. Pr Zannad is Professor of Clinical Pha rmacology
at the Nancy University. He is the Coordinator of the Nancy CIC-P and chairs the CIC
thematic network for cardiovascular disorders. Pr G Salles in Professor of Oncology at the
Lyon University Hospital, and Dr B François is specialized in reanimation at the University
Hospital of Limoges, coordinator of the CIC of Limoges and chair of the national network
CRICS (Clinical Research in intensive Care and Sepsis) funded by the Cengeps.
Primary network aim should be science production measured as the efficiency to complete
the clinical studies in a given time frame and the obtention of high levels publications in
peer-reviewed medical journals and data presentations at leading international
congresses.
Following models observed in various countries (Kompetenznetze in Germany17, or NIHR
Clinical Research Networks18 in England), and taking advantage of existing investigation
networks and specialized collaborative groups already developed in some areas, this task
is designed to support a better structuring of efficient networks. Networks are cost-effective
organizations for multicenter studies, carried on at a regional, national or international
level, depending on the disease epidemiology and the scientific question raised. These
networks must be able to carry clinical trials from design to execution. Programs supported
                                                                                                                         
17
18

www.kompetenznetze-medizin.de
www.crncc.nihr.ac.uk

39 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
by the networks can include observational and interventional trials. For the latter, trials
should range from early stage studies through to multicenter, international, randomized
controlled trials. Such networks must have the ability to support small, medium and/or
large clinical trials; they should generally have the capacity to perform translational
research (biology, imaging) and to generate ancillary projects, from, respectively, the
material and the data generated by the clinical trials.
Depending on their experience, size, organization, geographical spread, patients pathways
of recruitment (specialized centers or primary care organizations), the networks may need
differentiated support. However, some common ground can be defined. This includes the
existence of a dedicated coordinator and/or coordinating centre. The network should have
its own disease-oriented operational organization or be linked to a hospital Clinical Trial
Unit with specific expertise in the network topic, in order to offer a full range of clinical
research services constituting a coherent and comprehensive academic research
organization, from advice in project design through to full project management and
analysis. The network resource (or the dedicated support structure) must primarily provide
basic methodology, project management skills (including administrative, and regulatory
requirements for large scale trials), data management (randomization, CRF conception,
data entry and check) ideally through a high quality data center, a biostatistics unit,
organization of on site-monitoring, and quality assurance. Dedicated biobanks and/or
specific central labs are recommended, usually in partnership with hospitals and INSERM.
Some of those tools/tasks could possibly be shared with hospital-based organizations but
the need to foster specialized competent human resources should allow direct human
resources management by the network. For imaging or some other tasks, e.g. pathology
review, central platforms should be available, whenever applicable to the disease area.
International research will be encouraged through connection with other existing networks,
in particular in the EU.
Within the F-CRIN project, WP6 will carefully work within the steering committee with all
other relevant WP including WP7 (CTUs) and WP8 (data centers) for the scientific
coherence of the choice in supporting these 3 types of structures, WP2 (evaluation), WP4
(common procedures) and WP5 (training).
The networks facilitate recruitment in clinical trials whoever the sponsor of the study is:
this includes industrial sponsors but the network should also develop is own research.
Industrial partnership is encouraged, the network can also drive sub-studies of existing
trials from pharmaceutical companies. This initiative is complementary to the CeNGEPS
support that targets networks mostly active in industry-sponsored trials and in disease
areas of strong industry investment (cancer, brain, metabolism, inflammation and
infection).
All networks could be linked in a large project sharing the same trial management tools
with rigorous quality control and assurance, but also providing regulatory and quality
insurance expertise especially for international studies.
Dissemination of information on the networks’ capabilities and competencies will be
insured by each individual network and by the project.
Specification will also define the level of funding for each network, and the nature of
supported costs.

40 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

DELIVERABLES
> Specification for the disease-oriented networks

M18

> Call for application of networks

M18-M24

> Follow-up and audit of the selected Networks from

M24 will be implemented
in
collaboration
with
WP1 and WP2 projects
managers (phase II)

BUDGET
Personnel: 24 person-months
- 1 FTE for WP management during the first 24 months of the project
0.5 FTE will join the Executive Unit for the Phase II of the project (Month 2460)
Investment costs: 5M€
- 5M€ will be allocated for the competitive calls (10-12 networks)
Operation costs: 50K€
- Meetings (25K€/2yr)
- Travels (25K€/2yr)

41 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

WP7
Duration

CLINICAL TRIAL UNITS (CTU)
60 months

Start date

WP leader

G. Chêne

Task leaders

MC Woronoff, Y. Deugnier

Personnel

24 person-months

Investment costs

5 M€

Operations costs

50K€

Month 1

The objective of this work package is to provide an effective mechanism for the
management of competitive clinical trials at the international level, including Pan-Europen
trials, through the upgrading and certification of existing structures able to act as Clinical
Trials Units (CTU). This work will allow preparing a specific call to establish a task force of
a limited number of CTUs (up to M24) able to take over the management of large
international clinical trials (M24-M60).
Dr G Chêne is Professor of Epidemiology at the Bordeaux University Hospital, coordinator
of the Bordeaux CIC-EC and of the ANRS Clinical trial Unit. Dr MC Woronoff is Professor
of Epidemiology and Public Health at the Besançon University hospital. Professor Y
Deugnier of the University of Rennes, President of the DRCI of the Rennes University
Hospital and Coordinator of the Rennes CIC-P.
A clinical trials unit (CTU) is a unit with substantial experience in designing (protocol
preparation, study design), conducting (coordination, monitoring) and analysing (statistical
analysis and interpretation) clinical trials. They have established strong links with 1. A
sponsor since they prepare documents needed for submission to ethical or regulatory
authorities and monitor pharmacovigilance and other sensible data, and manage the whole
databasis being monitored, 2. a data center since they implement randomisation, and
monitor and manage all data needing analyses, 3. Investigator networks in one or several
disease areas as trial management is best handled by methodologists with accurate
knowledge in the field.
Close interactions with other WPs will be established, in particular WPs 4, 5 and 7, to allow
the highest possible standards and quality for the trials. Monitoring based on a priori riskassessment

42 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
Task 6a - Specifications of a F-CRIN CTU
This task will aim at:
-

establishing specifications needed for a F-CRIN CTU (i.e able to take over large
international clinical trials), including existing or potential links with the coordination
of an investigation network, with a data centre, with an Aviesan ITMO and with an
IHU and the potential to implement common tools of F-CRIN as defined in WP4,
and level of funding;
- identifying existing resources able to act as F-CRIN CTU;
- strengthening existing CTUs or favoring merger of existing resources to form new
CTUs reaching the critical size and competence.
This task will end with a competitive call to establish/certify 5 to 7 CTUs reaching a critical
size in terms of resources and level of activity, preferably disease-oriented.
Task 6b - Establishment of the CTU task force
This task will start as soon as the call has selected the CTUs and will aim at:
-

developing standardised processes for trial coordination including protocol
management, clinical site coordination and data collection and transmission (in
collaboration with data centers);
implementing these procedures in the management of the clinical trial(s)
conducted by F-CRIN;

-

DELIVERABLES
> Specification for the CTUs

M18

> Call for application for CTUs

M18 to M24

> Follow-up and audit of the selected CTUs will be managed from M24 in collaboration
with WP1 and WP2 (phase II)

BUDGET
Personnel: 24 person-months
- 1 FTE project manager for the coordination of the project during the first 24
months of the project
0.5 FTE will join the Executive Unit for the Phase II of the project (Month 24-60)
Investment costs:

5M€

- 5M€ will be allocated for the competitive calls (5 - 7 CTUs)
Operation costs: 50K€
- Meetings (25K€/2yr)
- Travels (25K€/2yr)

43 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
WP8
Duration

DATA CENTERS
60 months

Start date

WP leader

C. Alberti

Task leaders

N. Best , JC Barbare

Personnel

24 Person-months

Investment costs

5M€

Operations costs

50K€

Month 1

The objective of this WP is to provide a comprehensive framework for data centers as a
support for high quality clinical investigation and in collaboration with clinical trials units.
This will be accomplished through the upgrading and certification of existing structures
able to act as data centers and to participate in national and multinational trials. This will
be performed through the preparation of a specific call for the creation / certification of data
centers, after definition of the relevant specification, then establishing a task force of a
limited number of data centers, up to 5, able to take part in the realization of large national
and international clinical trials.
The leader of WP8 is Dr C Alberti, Professor of Epidemiology and Public health at the
Robert-Debré University hospital in Paris. She is also the Coordinator of the CIC-EC of the
Robert Debré University Hospital. Mr N Best is General Director of the University Hospital
of Nîmes. Dr JC Barbare Professor of gastro-Enterology at the Lyon University Hospital
and Co-Director of a Department of INCa
By reducing the access costs, public support will strengthen the attractiveness of the
French data centers for academic high-quality multinational trials. These professional data
centers will also be available for industry, particularly biotechnology- and medical deviceSMEs.
The activities of this work package will be organized into 2 tasks with establishment of
close interactions with WPs 4, 5 and 6.

Task 7a- Specification of F-CRIN data centre
This task will aim at defining specifications needed to qualify F-CRIN data centre. Different
aspects will be envisaged:
-

Definition and missions of a data centre in interaction with WP6

44 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
-

Necessary resources in terms of human (qualification, experience, continuing
education,…) and informatics (computer, software, data collection, data protection,
data transmission, link with other data bases as for examples : the medical
information system and health insurance), …
- Quality assurance, SOPs, audit
- Existing or potential links with the coordination of an investigation network, with a
CTU, with one or more Aviesan ITMO and IHU and the potential to implement
common tools of F-CRIN as defined in WP4, and level of funding.
The certification criteria should be in line with the ECRIN criteria for certification of data
centers for multinational clinical trials19.
Task 7b - Management of the call
The activity will consist of launching call for certification of data centers and to support the
selected centers by implementing procedures necessary to qualify a F-CRIN data centre in
line with ECRIN.

DELIVERABLES
> Specification for the data centers

M18

> Call for application for data centers

M18 to M24

> Follow-up and audit of the selected data centers will
collaboration with WP1 and WP2 (phase II)

be

managed

from

M24

BUDGET
Personnel (person-months): 24 person-months
- One FTE for the coordination of the WP during the first 24 months of the project
0.5 FTE will join the Executive Unit for the Phase II of the project (Month 24-60)
Investment costs: 5M€
- 5M€ will be allocated for the competitive calls (5 - 7 CTUs)
Operation costs: 50K€
- Meetings (25K€/2yr)
- Travels (25K€/2yr)

                                                                                                                         
19

Web Ecrin data centre specifications

45 /309

in

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

WP9
Duration

EUROPE – CONNECTION TO ECRIN
60 months

Start date

WP leader

J. Demotes

Task leaders

P. Garel

Personnel

60 person-months

Investment costs:

2,5M€

Month 1

The European Clinical Research Infrastructures Network (ECRIN, www.ecrin.org) is a
distributed infrastructure designed to enable multinational cooperation in investigatordriven clinical research, providing access to patients throughout Europe, with a major
expected impact on science and healthcare. ECRIN supports multinational clinical
research projects through the provision of information, consultancy and services. It also
supports the structuring of the clinical research capacity both at the national and the
European levels, particularly supporting the cross-border connection of disease-oriented
networks.
ECRIN is a network of national networks, connecting national clinical research
infrastructures (the CIC network for France). It currently covers 14 countries in Europe,
and France is the host country for its coordination, located at INSERM headquarters. The
ECRIN staff is composed of a core team plus a network of European Correspondents (EC)
hosted in each national hub. Adjoined to each national hub is a national clinical research
infrastructure, composed of CTUs and CRCs able to support clinical research in any
disease area.

46 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
ECRIN is currently an FP7-funded infrastructure project but after 2011 it will become an
international organisation with a legal status (ERIC for European Research Infrastructure
Project). The national clinical research infrastructure will not be part of the ECRIN-ERIC,
but linked to the ECRIN-ERIC through a project agreement including provisions on their
capacity to provide services, on the quality assurance and the cost of services.
• Support and services
Information, consultancy and services are coordinated by the network of European
Correspondents. The final provider can either be the European Correspondent, the CTUs
and other structures in the national clinical research infrastructure, or an external
subcontractor. The quality assurance system is based on internal instructions binding for
the ECRIN staff, and on quality policies setting the quality requirements of the CTUs and
other structures in the national clinical research infrastructure
Core set of information and consulting items during the preparation of the clinical
research project. Does not require submission to the ECRIN Scientific Board:
Adaptation of protocol to local context
Information on regulatory and ethical requirements
Information on clinical trial sites and participant recruitment
Information on clinical trails units
Information on insurance
Information on cost evaluation and funding opportunities
Information on contracting

Core set of services provided during the conduct of the clinical research project,
pending approval by the Scientific Board:
Submission to, and interaction with, competent authorities and ethics committees
Support with insurance contracting
Adverse event reporting
Monitoring
Data management
Training of study personnel
Investigational medicinal product management
Blood and tissue samples management

47 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
ECRIN also develops e-resources for multinational trials, including a repository for
regulatory information, a CTU catalogue, and an e-learning tool (ECRIN campus). ECRIN
also implements a certification strategy for data centres.
• Access policy
Scientific assessment of the projects is necessary to ensure their scientific excellence,
their medical relevance, their methodological and ethical soundness. Access to ECRINcoordinated services therefore requires evaluation of the full protocol by the Scientific
Board; access to information and consultancy does not need such approval. The Scientific
Board is composed of an internal board, and of a panel of external peer-reviewers asked
to provide their opinion (except if the protocol was already approved by independent peerreviewers). In addition, an evaluation of the feasibility and logistics is performed by the
network of European Correspondents.
• Contracting and cost policy
Services require a task delegation contract with the sponsor. Once the ERIC status is
obtained, ECRIN will be able to propose flexible solutions including a one-stop-shop
approach for contracting and payment (with a single task delegation contract between the
sponsor and ECRIN, and agreements for subcontracting between ECRIN and the final
service providers).
The cost policy is based on a not-for-profit rate for support to the public research
community. Furthermore, information, consultancy, the coordination of services, and some
specific services (ethical and regulatory submissions, after the creation of the ERIC) will be
offered without charging costs to the sponsor as they will be supported by the ECRINERIC budget.
• Additional impact
ECRIN not only facilitates multinational cooperation in clinical research, but also fosters
o the structuring of the national clinical research capacity and the
development of harmonised tools and practice
o its pan-European expansion and capacity building
o the support to the structuring of disease-oriented networks
o the improvement and harmonisation of national and EU legislation
o education and training programmes
o the lobbying for multinational funding to clinical research projects
o the optimal use of data
o the communication with patients, citizens, scientists and policymakers.
BUDGET
Personnel:

60 person-months

- 1 FTE position will be allocated to the Hospital partner to ensure appropriate
connection between ECRIN and the public hospitals, both for the provision of
services and for the consistency of the structuring of clinical research capacity at
the national and EU level.
Investment costs: 2,5M€
- 2.5M€ (500k€ per year over 5 years) will be allocated to INSERM as the national
contribution to the European coordination of ECRIN. In case a financial
commitment is secured in the 2011 budget law as the sustainable funding to the

48 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 
ECRIN-ERIC infrastructure (Article 13 of Programme 172), this financial support will
not be requested.
This corresponds to the national contribution expected from France for the ERIC,
based on the rules defined in its statutes :
- a fixed contribution to cover the cost of national European Correspondent :
100k€/y
- a variable contribution to cover the cost of the core team: 250k€/y if GDP >
$1000bn
- and an additional contribution for the host country : 150k€/y
(for details, see ECRIN business plan in the Appendices (Appendix 5)

49 /309

APPEL A PROJETS
INFRASTRUCTURES /
CALL FOR PROPOSALS
2010

Acronyme du projet / Acronym:

F-CRIN
DOCUMENT SCIENTIFIQUE B /
SCIENTIFIC SUBMISSION FORM B

 

5. TRAINING, DISSEMINATION AND EXPLOITATION OF RESULTS
 
5-1. Expected impacts of the project
a) Impact on academic research
This program is expected to strongly impact the academic clinical research in France
through:
-

-

-

an increased competitiveness in the quality and amount of publications
an increased capacity to reach the clinical proof of concept for translational research
projects
an increased quality and credibility of data
a better capacity to develop innovative therapeutic, diagnostic or preventive health
products developed from academic research, including personalized medicines and
biotherapy
an improved capacity to run large investigator-initiated randomized clinical trials on
new indication of already marketed drugs, or on treatment optimization (comparative
effectiveness research). It is common observation that in many fields, French
investigators lack robust academic facilities to run academic multicentric and
multinational studies. This is a priority for the F-CRIN project.
the capacity to initiate, and to participate in multinational trials (pan-EU, and EU-US
the capacity to develop large databases to be share with other research groups, from
private or public environment, in order to allow meta-analyses approaches and
increase the power of analyses.
the professionalism of the infrastructure to encourage industrial sponsors to enlarge
and enrich their usual Phase III trials primarily designed and implemented for
regulatory purposes to ancillary programs with high added scientific value, and to
share their own clinical trial databases with academic researchers for scientific
purposes
the capacity to attract FP7 funding for investigator-initiated clinical trials, IMI funding in
conjunctuion with ECRIN, as well as NIH funding for comparative effectiveness
research.
b) Impact on industry-sponsored clinical trials

It will also foster the attractiveness for industry-driven trials, particularly through:
-

the investigator networks (in synergy with the CeNGEPS funding)
the administrative procedures and unified study management tools
the quality of the infrastructure and the dissemination of the quality assurance policy
and of quality audits, making high quality investigation centres and networks also
available for industry trials
the availability of clinical research infrastructures able to provide the full range of
services for SMEs in the field of innovative therapies from drugs to biotechnology and
medical devices.

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