France: 637 missing clinical trial results spark calls for transparency
Major French trial sponsors have failed to make an estimated 637 clinical trial results public on the European trial registry, a new report shows. Out of 20 French institutions running Covid drug trials, 15 are currently in violation of transparency rules.
Research institutions’ failure to rapidly share trial results in line with European Union transparency requirements slows down the pace of medical progress and raises the risk of medical research never being made public and becoming research waste.
"Cancer patients give their time, blood and tissue to clinical trials and they need all results to help make vital treatment decisions. These results must be published in an accessible way as early as possible. Patients live with great uncertainty, especially within data-sparse diseases. All data is important to them,” said Gilliosa Spurrier-Bernard, president of patient group MelanomeFrance and chair of WECAN.
FRENCH UNIVERSITY HOSPITALS PERFORM WEAKLY
Overall, large pharmaceutical companies in France perform strongly, but of the 27 largest non-profit research institutions, only two – Lymphoma Study Association (LYSA) and the Centre Léon Bérard – have a strong disclosure record.
The vast majority of French university hospital centres (CHUs) have not uploaded a single trial result onto the registry. Assistance Publique - Hôpitaux de Paris, the largest research institution, alone has failed to make the results of an estimated 152 drug trials public on the databank. Overall, French institutions perform significantly worse than their counterparts in Germany and the UK.
David Pérol, Head of Clinical Research at the Centre Léon Bérard, explained that his institution is “strongly committed to excellence in medical research, and transparency is important to us and our patients. We have already uploaded the results for many clinical trials, and will upload the remaining results soon.”
WHO IS RUNNING COVID DRUG TRIALS IN FRANCE?
The report also examines the past disclosure record of twenty French companies and institutions that are running Covid drug trials involving 14,400 patients. Only one of these sponsors, Sanofi, is compliant with European reporting rules. The other sponsors have either violated the rules, or do not have an established track record.
Scientists cannot determine with confidence which French Covid trials are still ongoing and which have been completed because data on many trials are not being kept up to date
“The transparency of clinical trials is an ethical and scientific requirement that provides tangible benefits. It allows health agencies to make informed decisions favourable to the well-being of the population,” Patrick Lefas, president of Transparency International France, whose organisation co-published the report, commented on the findings.
FRENCH REGULATOR REMAINS SILENT
The report recommends that French drug regulator ANSM, the agency responsible for overseeing drug trial reporting, should contact trial sponsors whose results are overdue, ensure that data on the register is consistent and accurate, monitor compliance, and develop a mechanism for routinely and automatically imposing sanctions as soon as the EU Clinical Trials Regulation becomes national law in late 2021. ANSM did not respond to a request for a statement.
FRENCH HEALTH GROUPS CALL FOR MORE TRANSPARENCY
In response to the report’s findings, French health groups and experts are calling for more transparency.
Isabelle Boutron, Director of Cochrane France, said:
“The timely posting of clinical trial results onto a registry is crucial to allow high quality evidence synthesis and evidence-informed health decision-making.Results posted onto trial registries can be 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.”
Kévin Jean, epidemiologist and Member of the Board of Sciences Citoyennes, said:
“Results of clinical trials that remain hidden in drawers do not contribute to the advancement of knowledge, do not help to inform public decisions, and constitute an ethical breach towards the participants in these trials, who have agreed to take risks (all trials have them) to advance treatments. Public institutions are failing in their responsibilities here.”
Pierre Chirac, Member of the Editorial Board, Revue Prescrire, said:
"The main goal of clinical trials is to advance knowledge. Publishing their results is a scientific necessity and an ethical imperative. Publishing their results in the European Eudra-CT register is also a regulatory obligation, poorly fulfilled in France as shown by this study."
Xavier Masset, national coordinator for Universities Allied for Essential Medicines (UAEM) France, said:
The current lack of transparency is disappointing and carries significant implications for public health. UAEM France strongly encourages university hospital centers to make public the results of all clinical trials conducted within their institutions. Not publishing trial results severely affects the evidence base of clinical medicine, as crucial data (positive as well as negative) that could inform better medical management of patients remains missing."
Florian Naudet, Professor of Therapeutics at the University of Rennes, said:
"Transparency and openness are core values in science, and there is a moral imperative to share the results of clinical research. Because trials participants have agreed to put themselves at risk, we need to make the best use of clinical trial data. Keeping these data in a file drawer is both wasteful and a fertile ground for non-reproducible research. It is concerning to see that most French institutions (including mine) are performing badly in this respect. There is a need to align the incentives our hospitals receive with both quality of science and our duty toward clinical trial participants."
Philippe Ravaud, Director of the Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité, said:
"This important report emphasizes the need, beyond the responsibility of each researcher, to set up institutional mechanisms to remedy individual shortcomings and avoid damaging losses of important scientific information."
French public health advocate Alain Braillon said:
“These data show that public clinical research in France fails to respect a basic principle of science: transparency. This failure to share results from trials is doubly disloyal: to the taxpayers who funded the research and to the patients who agreed to participate in the research. This unacceptable state of affairs is unlikely to improve if clinical research divisions in public hospitals remain run, directly or indirectly, by the principal investigators.”
The report was published jointly by Transparency International France, MelanomeFrance, and TranspariMED. The three groups will publish a follow-up report later this year to track French institutions’ progress.
The QUEST clinical trial reporting manual and other useful resources are available on the TranspariMED website.
DOWNLOAD THE FULL REPORT
Report in French language:
Report in English language:
Comments