Table 1 Identified weaknesses of the French clinical research environment and remedial actions undertaken to make it more attractive and competitive [12–17]
Identified weaknesses | Remedial actions |
|---|---|
Disinterest in industry-sponsored clinical research | Creation of a single-point of contact for industries by funding the following posts: |
• No clearly-identified referent | • Inter-regional contact point for industry |
• Industrial referent (and administrative assistant) in the DCRI in each teaching hospital | |
• Positive image of French clinical research by the professionalism and dynamic structures with a culture of results, particularly in terms of patient recruitment delays and objectives | |
Fragmented clinical research resources between research institutes and hospitals/clinics | • No additional structure but annual call for proposals for CRT posts to strengthen the existing inter-regional structures |
• Development of tools for feasibility surveys | |
• Funding of CRTs in non-teaching hospitals to increase capacity for patient recruitment | |
Confusion about the meaning of ‘network’ | Annual funding call for ‘support for clinical investigation network’: |
• In the hospital setting, ‘network’ is often associated with care or healthcare networks | • Development of a thematic national clinical investigation networks for international collaborations |
• Definition of missions and clear added value | |
• Development of standards and performance criteria | |
No common information system | Development of SIGREC, an information system dedicated to the administrative management and follow-up of clinical trials (industry-sponsored and investigator initiated) |
• Faster implementation of clinical trials | |
• One-stop information source for all sites – assess availability for new trials | |
• Long-term aim – to reduce paperwork and provide statistics on number of studies/investigator etc. | |
Long delay before clinical trial implementation | • Development of model contracts and financial |
• Appendices (in French and English) ➔ save time | |
• In 2014, possibility to set up contract via SIGREC (paperless environment) | |
Isolated investigators | • Almost 500 qualified clinical research staff have been hired and trained via three calls for proposals |
• Rarely associated with specific, qualified CRTs or other staff | • These staff are dedicated to industry-sponsored clinical research |
• The professionalism of the teams and the improved organisations of the sites have contributed to a more attractive and competitive clinical research environment in France |