French government report calls for new law to make clinical trial reporting mandatory

A landmark report commissioned jointly by the French Ministries of Research and Health sets out a comprehensive roadmap to reduce research waste in clinical trials and accelerate the publication of results.

Notably, the report calls for introducing first a regulation and then national legislation requiring the results of all clinical trials to be made public on trial registries within one year.

According to the French Open Science Monitor, only 44% of French clinical trials completed during 2022 had made their results public one year later, including only 15% of academic trials.

The figure above probably overestimates the scale of research waste due to the methodology used. However, multiple studies consistently show France significantly lagging behind the UK and Germany in terms of curbing research waste, as in the example below.

Moving from zero to hero

The World Health Organisation has demanded all clinical trial results to be made public within one year of trial end. For drug trials, this is already a legal requirement in France and all other European Union countries.

The new report sets out a long list of recommendations for achieving this goal.

“The group recommends that the posting of results be integrated into clinical research training programmes, into the financial arrangements for clinical trials in France, into the collective and individual assessment procedures in clinical research, and that the issue should be considered in institutions’ strategies relating to scientific integrity.”

“The group also suggests expanding the national and European regulations to all clinical trials. Indeed, there is no ethical, scientific or public health rationale that justifies the current situation where nonpharmacological clinical trials are exempt from the [legal] obligation to post their results.”

“The most important thing in our report is that we involve everyone” in fixing the problem, working group chair Professor Philippe Ravaud told the newspaper Le Monde.

Sweeping reform agenda

Specific measures recommended to various parties in the clinical trial ecosystem include:

• Starting in 2025, via regulation, make it mandatory to post the results of all clinical trials as defined by WHO, beyond solely drug trials, onto clinical trial registries within one year. Then additionally adopt legislation.

• Change the assessment criteria of sponsors and take into account results posting in funding indicators.

• Send each sponsor a report that includes a list of their trials with unposted results in order to prompt them to identify and correct posting failures.

• Send reminders to principal investigators who have not transmitted to the sponsor the information needed to post the results of completed trials, before the deadline (one year after the trial ends) is reached.

• All funders should publish indicators on the posting and scientific publishing of results for the trials they fund. 

• Make payment of the final funding instalment conditional on posting results within twelve months after the trial ends.

• Develop an open-source tool to generate a template of results to be posted directly onto clinical trial registries. 

• Explicitly include trial publication in the scientific integrity policies of clinical trial sponsoring organisations.

Pioneers in continental Europe

As far as TranspariMED is aware, until now the UK has been the only country worldwide to publish a comparable national strategy to improve clinical trial transparency.

Years later, the UK strategy has led to very strong improvements in clinical trial registration, and probably also significantly improved the reporting of results. Notably, a list of all trials involving UK patients that received ethics approval is now publicly available - a global first.

However, the UK Health Research Authority has so far failed to deliver on its promises to automatically register trials, to systematically monitor whether or not results are made public, and to actively follow up on missing results.

In the United States, some trials have long been required to disclose results by law. Most large American sponsors now consistently and rapidly upload the results of such trials onto the ClinicalTrials.gov registry, despite persistent foot-dragging on enforcement by the U.S. Food and Drug Administration.

There are also efforts to improve clinical trial reporting in Germany and the Nordic countries, but these are typically led by national Cochrane groups rather than driven by national governments.

Till Bruckner, founder of TranspariMED, said:

“The French report is excellent and sets out a very clear, realistic and actionable roadmap for ending research waste.”

“If these measures are fully implemented, they will generate huge savings for French taxpayers as well as improving the global medical evidence base.”

“The key challenge ahead is for French patients, doctors and health groups to keep their eyes on the ball and ensure that this positive momentum is maintained, and that all recommendations are rapidly translated into practice.”

The report is available online in both English and French language. It includes multiple annexes summarising relevant global norms and legal frameworks.