France: Key institutions pledge to make clinical trial results public
Five of France’s largest medical research institutions, including Assistance Publique - Hôpitaux de Paris and Inserm, have pledged to make clinical trial results public on the European database.
Their pledges come in the wake of a recent report showing that France’s 27 largest non-commercial trial sponsors had failed to make hundreds of clinical trial results public, in violation of transparency rules.
Assistance Publique - Hôpitaux de Paris (AP-HP)
With a portfolio of over 300 drug trials, hospital network AP-HP is France’s largest public trial sponsor. Referring to the recent report, an expert commissioned by AP-HP to conduct a review of its scientific integrity systems told newspaper Le Monde that:
"This investigation is important, because the provision of [results on the trial registry] ensures that the public has access to the data. It will help explain what we're doing. This is a change of culture for everyone and it is necessary that everyone gets used to this, and that we find out what technical and financial means to put in place to resolve this problem.”
AP-HP is the second-largest non-commercial trial sponsor in the whole of Europe. All of the top five non-commercial sponsors on the continent have now committed to tackling the issue.
Inserm is widely seen as one of the national leaders in cutting-edge medical research. Hélène Espérou, head of the institution’s clinical research centre, told Le Monde that:
"We are in the process of organizing a process to ensure that these results are entered into the database, with the establishment of a comprehensive set of measures, including online trainings, awareness raising, and tracking of the publication of results on [European trial registry] EudraCT.”
Intergroupe Francophone de Cancérologie Thoracique
IFCT works to improve the survival rates and quality of life of patients with lung cancer. It is a registered charity that brings together hundreds of medical professionals. IFCT is responsible for managing a portfolio of 18 drug trials. In a recent Twitter exchange, IFCT informed TranspariMED that:
"IFCT is actively working towards a 100% reporting rate"
LYSA and Centre Léon Bérard
The Lymphoma Study Association (LYSA) and Centre Léon Bérard announced their intention to make all results public before the report was launched. Both institutions expect to achieve a 100% reporting rate in the near future. Centre Léon Bérard has already uploaded several clinical trial results in the weeks since the report was published, as this screenshot from the EU Trials Tracker shows:
Note: An additional French university hospital centre (CHU) has recently signalled that it also intends to improve its trial reporting, but has not yet made a public statement.
French regulator ANSM promises to take action
French sponsors face a fine of 15,000 Euros or up to a year in prison for failing to report clinical trial results once the European Union regulation fully comes into force, ANSM noted in a letter to Transparency International France. (TranspariMED is unclear as to whether ANSM can directly impose these sanctions, or will have to go to the courts to do so.)
In the short term, ANSM will include a reminder that results must be reported when it authorises new drug trials.
ANSM also claimed that it had repeatedly informed sponsors of drug trials of their obligations, but left unclear whether it had contacted sponsors directly, or simply uploaded guidance material on its website. ANSM did not specify whether it uses the inspection process to check up on sponsors' compliance with their trial reporting obligations, or plans to do so in future.
ANSM's full letter can be downloaded here:
TranspariMED strongly welcomes leading French institutions’ commitments to transparency.
Going forward, TranspariMED in collaboration with its partners Transparency International France and MelanomeFrance will publish regular progress reports to track French sponsors’ progress over time.
Universities, hospitals and charities that wish to improve their performance can access a collection of useful transparency tools on the TranspariMED website.