French health groups challenge public funders INSERM and CNRS over unreported clinical trials
A coalition of 16 French health groups has challenged the two largest medical research funders in the country over their weak clinical trial transparency safeguards.
In an open letter, the groups pointed out that a 2017 assessment of twenty top global research funders had given both INSERM and CNRS weak marks for their clinical trial registration and reporting policies (see chart below).
UPDATE: INSERM formally responded to the letter in January 2019, response here. CNRS have yet to respond.
The letter also noted that CNRS has yet to sign up to the WHO Joint Statement, through which funders commit themselves to adopting strong transparency standards. INSERM signed the statement in May 2017.
Research funders in other countries are already far ahead of INSERM and CNRS in terms of meeting WHO standards:
The Medical Research Council in the UK has already begun checking whether the clinical trials it funds have been registered and have reported results; the MRC makes the results of these audits public.
UK trial funders NIHR and Wellcome Trust are also working to set up similar monitoring systems. NIHR recently unveiled a strong draft transparency policy, and Wellcome has a long-standing policy of withholding the final tranche of research grants until clinical trial results have been made public.
Pressure on German funders to fully adopt WHO best practices is also growing in the wake of a recent study showing that ethics violations and research waste are widespread at German medical universities.
In the United States, the National Institutes of Health have announced that researchers who fail to register clinical trials or report results will in future no longer receive research grants,
The FDA is preparing to (finally) impose fines on trial sponsors who fail to post results within the legal 12 month timeframe. Similar measures are likely to be adopted in the UK soon.
Failure to register clinical trials and report their results is unethical, harms patients, undermines public health, and wastes public research funding.
The French health groups wrote that:
“We demand that French public research organizations catch up on their obligation to make clinical research data fully accessible to citizens, health professionals and research actors.”
Specifically, the groups called on:
CNRS to sign up to the WHO Joint Statement
CNRS and INSERM to fully implement, as soon as possible, the provisions of the WHO Joint Statement, including ensuring that the summary results of all clinical trials are posted within 12 months after the end of a trial
CNRS and INSERM to engage in a public dialogue on the implementation of the WHO Joint Statement and the [French] National Plan for Open Science
Data from the EU Trials Tracker shows that INSERM has failed to post the results of at least two clinical trials for which it is legally responsible under EU regulations.
Four more INSERM-sponsored trials have inconsistent data on the European registry. One CNRS-sponsored trial also has inconsistent data.
These figures are likely to be only the tip of the French research waste iceberg, for three reasons:
First, many of the 24 INSERM-sponsored clinical trials listed as ‘ongoing’ were probably completed long ago and are thus overdue to post results. Several INSERM trials listed as ‘ongoing’ were started more than a decade ago.
Second, the European registry only lists a minority of all clinical trials conducted in France. Only certain types of trials can be registered on the European database. Many more clinical trials are registered elsewhere. For example, 76 clinical trials directly sponsored by INSERM are listed on the American registry Clinicaltrials.gov alone. INSERM has posted the results of only two of those trials there.
Third, CNRS and INSERM almost certainly fund far more trials than they directly sponsor. For example, many non-commercial clinical trials in France are run by Centres Hospitalier Universitaires, often with public funding. CHU Toulouse alone has sponsored 48 trials that are listed on the European registry, and 313 trials listed on the American registry, It has not posted the results for any of those trials, some of which may have been funded by CNRS or INSERM.
(Note that the “sponsor” is the party legally responsible for posting trial results. Usually, the organization running a trial – such as a CHU or university – is the trial sponsor. The funder of a trial is almost never the sponsor, unless it directly runs the trial itself.)
The coalition of health groups calling for greater transparency includes Medecins du Monde, Prescrire, Universities Allied for Essential Medicines, numerous patient groups, and two doctors’ associations, illustrating the broad range of stakeholders in France who are concerned about unregistered and unreported clinical trials.
In August 2018, Transparency International, Cochrane and TranspariMED had already written to INSERM and CNRS to prompt them on their transparency plans. INSERM has replied to the letter, highlighting ongoing transparency efforts, but CNRS has not responded to date.
TranspariMED plans to re-assess the transparency policies of public trial funders worldwide in 2019.