September 01, 2017
Bulletin interne de l'Institut Pasteur
The Institut Pasteur signs the joint statement on public disclosure of results from clinical trials
The Institut Pasteur sponsors and takes part in clinical trials designed to speed up the clinical development of diagnostic tests, health products (vaccines, medicines, etc.) and other therapies. In regulatory terms, the stages in a clinical trial are governed by a strict national and international framework.
The Institut Pasteur is committed to playing its part in the international effort to enforce compliance with clinical trial procedures. To this end, it agreed to be one of the first co-signatories of the joint statement on public disclosure of results from clinical trials, initiated by WHO, together with other academic institutions involved in global health. Several funding bodies have also signed this declaration, calling on the teams whose projects they support to comply with these standards.
By signing this declaration, the Institut Pasteur undertakes to register the details of any clinical trials* it initiates, before the inclusion of the first patient, in accordance with applicable legislation. It also undertakes to make the results of these clinical trials (whether positive or negative) publicly available in a timely manner following the end of the trial, either in the clinical trial registry or via a scientific publication.
By May 2018, the Institut Pasteur's Medical Affairs and Public Health Department, which coordinates the administrative aspects relating to clinical trials, is required to describe, disclose and implement the procedure it will use to fulfill these commitments. The Institut Pasteur also undertakes to inform WHO of any difficulties it encounters in implementing these measures.
As one of the "pioneers" of this statement, together with a handful of other organizations, the Institut Pasteur was given the opportunity to submit a comment by President Christian Bréchot.
Please feel free to contact Nadia Khelef for any general information about relations with WHO and other signatories on this topic, or get in touch with the Medical Affairs and Public Health Department for technical details and information about the implementation of this strategy.
* A clinical trial is defined by WHO as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.