Clinical trial transparency in France: far below European standards
French university hospital centres (CHUs) have failed to post the results of the vast majority of their clinical trials, data compiled by Hospimedia shows.
Academic institutions, trial funders and even the national regulator in France operate far below European transparency standards.
Out of twenty hospital centres assessed by Hospimedia, only two centres – Angers (its single verifiably due trial has posted results) and Nantes (two out of three due trials have posted results) – have uploaded any results onto the European trial registry. The remaining 18 centres have not uploaded the results of any clinical trials, Hospimedia reports.
Some French university hospital centres are likely to argue that many of their trials have published results in academic journals. However, European Union transparency rules clearly state that this is not sufficient.
There are good reasons for this. Trial results posted on registries typically contain more comprehensive and accurate data than journal articles do, can be openly accessed by doctor and patients, reduce the risk of research waste, and accelerate progress in medical research.
The true number of CHU trials missing results is likely to be even higher than Hospimedia's data suggests.
Hospimedia compiled the reporting performance data using the EU Trials Tracker. The Tracker undercounts the true number of due trials by French CHUs that are missing results because it relies on European trial registry entries. On the registry, many French trials that were completed years ago are falsely listed as “ongoing”.
For example, Assistance Publique – Hôpitaux de Paris (AP-HP), the largest trial sponsor among the CHUs assessed, has sponsored a total of 238 trials since 2004. Of these, only nine trials are listed as having been completed more than a year ago, and thus as missing results.
However, a further 189 trials are listed as not yet due, even though dozens of them were initiated over a decade ago. Most of these trials were almost certainly completed long ago and are thus obliged to make their results publicly available.
The French National Agency for the Safety of Medicine and Health Products (ANSM) has failed to update the status of a large number of trials.
(While pharmaceutical companies, universities and hospitals are responsible for uploading the results of the clinical trials they run, national medicines regulators like the ANSM are responsible for updating the status of those trials.)
Earlier this month, the Heads of Medicines Agencies from across the European Union co-signed a letter reminding clinical trial sponsors of their obligation to upload trial results. France’s ANSM is a Heads of Medicines Agencies member.
In February 2019, a coalition of 16 French health groups had challenged the two largest medical research funders in France, Inserm and CNRS, over their weak clinical trial transparency safeguards.
To date, neither public funder has audited whether its grantees make clinical trial results public, raising the risk of research waste.
Till Bruckner, founder of TranspariMED, said:
“French university hospital centres’ clinical trial reporting performance is deeply disappointing, as is the failure of the French National Agency for the Safety of Medicine and Health Products (ANSM) to keep up to date information that patients and doctors rely on. It appears that in France, both the regulator and the institutions it is supposed to regulate fall significantly short of established European transparency standards, as do public research funders. French taxpayers and patients deserve better.”
Note: Hospimedia’s article and data for each of the twenty CHUs it assessed are behind a paywall, but readers can access the full article by signing up to a free one-week trial of the website.
French CHUs, trial funders and the ANSM can use TranspariMED’s collection of Transparency Tools to strengthen their policies and performance.