Setting new standards for medical research transparency in France: IFCT
The oncology group IFCT has long been a front-runner in medical research transparency. It was one of the first French players to pledge to make all of its drug trial results public on the European clinical trial registry. A quick look at the EU Trials Tracker shows that this promise was kept:
In contrast, many other French institutions are still far short of meeting basic regulatory requirements. For example, the country’s largest sponsor, the hospital network AP-HP, still owes the public at least 45 clinical trial results. (The true number of overdue AP-HP results is probably closer to 200, but we cannot be sure as the France’s national regulator ANSM has failed to get French trial data up to date.)
While most of its French peers continue to fall short of even minimum transparency standards, IFCT has being working further improve the transparency of its clinical trials. It shared the summary below with TranspariMED, which we reproduce here in the hope that it will inspire other institutions in France and across Europe to up their game and do what is best for patients, science and society:
The French Cooperative Thoracic Intergroup (IFCT) is an independent, non-profit academic research intergroup specialized in thoracic oncology.
Its objective is to improve survival and quality of life for thoracic cancer patients. IFCT is responsible for managing a portfolio of 25 active trials (with 11 open to recruitment) and is strongly committed to transparency about its clinical research activity as follows:
Clinical trial registration
We register all interventional trials conducted in patients prior to trial initiation on Clinicaltrials.gov and on the Clinical Trials Information System (CTIS) which is now mandatory for all initial clinical trial applications in the European Union, as of the 31st January 2023. We also disclose on our public website summaries of our clinical trials and real-world evidence studies (RWEs) studies in scientific language.
Clinical trial reporting on trial registries
For all studies registered on the CTIS and ClinicalTrials.gov, technical summary results are submitted within 12 months of the end of the study. 100% of IFCT clinical trials results are now publicly accessible. IFCT has a dedicated and trained staff for purposes of timely registration of clinical trials, communication of research results, and publication of IFCT-sponsored trials and observational studies. Results posted onto these trial registries are usually made publicly available well before results are published in a peer-reviewed journal, and are usually more completely reported and can consequently be used for evidence synthesis.
Lay summaries
The new EU Clinical Trials Regulation introduces a requirement for sponsors to submit a summary of the results trials on the EU Clinical Trials Register, regardless of their outcome, in a format understandable to laypersons. IFCT has also taken positive steps on data transparency beyond current legislative/regulatory guidance and has made available on its website, since 2018, several videos in easy-to-understand, non-technical language so that patients can understand why the study was done, how it was done, and the results.
Publication of clinical trial results
We submit the results of all of our trials for publication in peer-reviewed journals or at scientific meetings regardless of the outcome to support scientific advancement.
Data sharing with researchers
IFCT has a structured database and a collection of biological samples and has set up methodologies to provide a framework for their use and sharing them for the benefit of large-scale scientific projects, while ensuring patients’ rights are protected. Patients are obviously notified of the possible use of their data and biological samples for research purposes prior to their treatment or participation in a clinical trial. The IFCT website also provides patients with additional information and updates on the re-use of their data.