About
In May 2017, Prof. Christian Bréchot, as the President committed the Institut Pasteur to comply with the WHO joint statement on public disclosure of results from clinical trials. This recognizes “the importance of transparency of clinical trials and timely sharing of research results, practices that are already in place in the institution. This should undoubtedly facilitate translation of research results into applications for the improvement of citizen’s health and avoid the losses of repeating unnecessary experiments”.
From July 2017 until now, the concerned stakeholders within the Institut Pasteur gave during a case-by-case approach the clues for an integrated monitoring which will ensure the compliance with this engagement for clinical trials sponsored by the Institut Pasteur.
Commitments
As a consequence of this commitment, any Institut Pasteur sponsored clinical trials should comply with the following commitments. Clinical trials are defined by the WHO (1) 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”
- Registration of clinical trial in a public registry that complies with the WHO requirements (e.g. Clinicaltrials.gov)
- Before the inclusion of the first participant in the trial
- Up-dated as necessary or at least reviewed on a periodic time-frame until the completion of the trial
- Results reporting
- To the competent authorities in compliance with timeframe and procedures set by the applicable regulations,
- To the scientific and medical community through publications in peer-reviewed journal within the best delays from completion of the samples and data analyses,
- To the public, through the registry, even if the results are inconclusive or negative
- Individual Participant Data (IPD) sharing when possible
- To evaluate by the time of the trials conception :
- whether IPD should and could regulatoryly be shared subsequently,
- how IPD sharing could be organized,
- which rules will govern the IPD sharing
- To implement the appropriate information to allow the possibility for the participants to freely consent for the IPD sharing
- within the contributing parties of the research project
- beyond the contributing parties of the research project
- To evaluate by the time of the trials conception :
(1) http://www.who.int/ictrp/en/
How to proceed for compliance
To guide and assist you to ensure your clinical trial is in compliance with the above commitments, you should contact the CRT Guichet Unique (crt-guichetunique@pasteur.fr)
This work was initiated in 2017 by Odile Gelpi as the Director for Medical Affairs and Public Health until Jan. 31th 2019.