Ensuring that the results of all clinical trials in France are posted

The Working Group on “Transparency and the publicising of the results of health research”, was appointed by the French Ministry in charge of Research, in conjunction with the French Ministry in charge of Health. It seeks to address the problem of publication bias, which is the tendency to prioritise the publication of positive results. However, if they are based on an incomplete, skewed understanding of research results, this bias may result in erroneous health policy decisions. This report makes recommendations towards all stakeholders involved in clinical research, and covers the entire scientific process and its funding. It places particular emphasis on the importance of posting clinical trial results in the registry used to declare them, within a maximum one-year delay after the trial ends. This sort of development is crucial in order to reduce publication bias. The posting of results involves the making public of aggregated data for the main results of a trial (i.e. descriptions of trial’s participants and their characteristics, primary and secondary results, and adverse events). This posting is not considered to be a peer-reviewed scientific publication, and is independent of any potential publication in a scientific journal. The posting of results is an ethical obligation, as stated by the World Health Organisation (WHO), the International Committee of Medical Journal Editors (ICMJE) and the World Medical Association. It is also a legal obligation that is subject to precise European regulations (as in the United States of America). Above all, the Working Group recommends that all stakeholders should communicate more effectively about the issues involved in posting clinical trial results and assist with the introduction of a clear means of organising these postings within reasonable timeframes. It underlines the benefit of having national indicators produced by the French Open Science Monitor, which should be applied to each sponsor, in order to encourage them to correct any potential shortcomings. Publishing guidelines should enable good practices to be implemented in the area. 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. To facilitate posting and improve quality, the group suggests that an open-source tool should be developed to generate the template of results to be posted. This tool could be implemented taking inspiration from both European regulations and the procedure in place in the U.S. clinical trial registry, ClinicalTrials.gov, in order to avoid introducing unnecessary complexity and divergence in the sponsors’ work. The group suggests that sponsors should get involved and undertake educational work in three phases to ensure that the results are posted: raising awareness before launching the trial, issuing a warning as soon as the trial ends, and, where necessary, issuing a reminder from twelve months after the trial ends. The group also suggests that the National Research Coordination Committee (CNCR) should be assigned the task, for a transitional period of 12 to 24 months of supporting sponsors to implement the Working Group’s recommendations. Similarly, the working group proposes that the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) (French National Agency for the Safety of Medicines and Health Products) should issue a reminder of posting obligations during its inspection missions and when communicating about clinical trials. 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 obligation to post their results. Lastly, the functionalities of the European CTIS registry need to evolve to meet the expectations of the international scientific and editorial communities regarding the posting of results. Furthermore, as CTIS does not cover all clinical trials, the question of where to post the trials concerned will arise.