A very large number of clinical trials are currently in progress in France. Their sponsors – namely, the entities assuming responsibility for them – are most often public research organizations or hospitals (academic research), as well as pharmaceutical companies. Inserm is currently responsible for 250 research projects, 150 of which are sponsored. The vast majority of these studies are financed by public or charitable funds.
At Inserm, the Directorate General entrusts clinical research sponsorship activities to the Clinical Research Unit, under the egis of the Public Health Theme-Based Institute. This unit assists the investigators with the various procedures:
- before the study: project preparation, expert appraisal (if applicable), obtaining of regulatory approval
- throughout the study
- up to its closure, with publication of the results
It must be noted that studies concerning AIDS and viral hepatitis are entrusted to ANRS, an autonomous Inserm agency devoted to these areas.
The deployment of Inserm clinical research activities is also based on the scientific and methodological expertise of its research structures and infrastructures, such as the Methodology and Management centers, the Clinical Investigation Centers (CICs) and the components of F‑CRIN, the French branch of its European Clinical Research Infrastructures Network. Certain head office divisions (notably Financial Affairs and Legal Affairs) are also involved, as well as the Regional Offices. Special relationships with the investigators/scientists and collaboration with external experts and partners enable studies to be run even more efficiently.
Over 250 studies ongoing, 150 of which sponsored
The scope of the studies sponsored by Inserm is in keeping with the requirements of the Inserm strategic plan and scientists. In concrete terms, this may cover:
- research in physiology and pathophysiology dedicated to elucidating the biological mechanisms or to preparing diagnostic and/or therapeutic strategies, primarily in the neurosciences
- early-phase studies, related to the development of products by Inserm teams (medical devices, innovative therapies and possibly « regular » medicinal products)
- clinical trials on rare and emerging diseases conducted abroad, whether in full or in part, particularly in the domain of emerging diseases (studies performed by the REACTing network)
- pilot phases of major innovations (novel technologies, multimodal methodological approaches, projects of the French Plan for Genomic Medicine 2025, etc.)
- general population intervention studies, including cohort ancillary studies
- studies driven by the Investigation Network Initiative of F‑CRIN, including those based on a public-private partnership
This scope goes beyond the national framework because the Institute sponsors international projects, particularly as part of European projects (H2020, IMI, ERC, EDCTP, etc.). At the current time, the Clinical Research Unit is managing some twenty studies of this type.
The Clinical Research Unit also assists scientists and investigators with their regulatory procedures concerning studies on collections or previously collected data. While this research concerns human subjects, it is however outside of the scope of the Jardé law because the subjects are not directly involved. Nevertheless, the regulatory framework requires that subjects having provided their samples or their data are protected: therein lies the role of the Clinical Research Unit.
When the patient viewpoint facilitates clinical research
Inserm works closely with patient associations to include them in the expert appraisal process for clinical research projects. For over ten years, the Institute has been training association members in the review of clinical research protocols. On a voluntary basis, these reviewers ascertain the clarity of documents issued to volunteers invited to participate in research sponsored by Inserm. Their viewpoint benefits everyone: the patients who are able to give truly informed consent to participate in the study, and the researchers who will benefit from greater volunteer compliance and more rapid regulatory procedures prior the start of their research.
Knowledge-sharing and transparency
Inserm – by signing the Joint Statement on Public Disclosure of Results from Clinical Trials promoted by the World Health Organization – has committed to disclosing the results of the trials for which it is a sponsor. Various concrete measures are already in place within this framework, to which others will be added according to procedures currently being defined, notably in view of the constraints related to the European General Data Protection Regulation.
Registration of clinical trials sponsored by Inserm
All clinical trials sponsored by Inserm are registered on the https://clinicaltrials.gov international clinical trials web platform, and possibly on other sites (at the request of certain investigators or funding parties).
The results of the vast majority of clinical trials sponsored by Inserm are published in peer-reviewed journals. Where possible, the final report summaries are submitted to the site(s) at which the trials had been declared.
The investigators are assisted by the Clinical Research Unit in providing the final report summary within the year following the closure of a study.
Sharing individual data
In its capacity as sponsor, Inserm owns the study data. Sharing individual data may be envisaged within the framework of some multipartner protocols, governed by specific agreements.