National medicines regulators must take action over unreported clinical trials, 18 patient and medical groups from across Europe warn today.
Over four thousand drug trials run in the European Union are currently in violation of European Union transparency rules, leaving large gaps in the evidence base that often make it impossible for doctors and health agencies to precisely determine how safe and effective medicines are, slowing down medical progress and putting patients at risk.
National regulators within each EU country are responsible for ensuring that pharma companies, universities and hospitals make the results of clinical trials public – but many regulators are not even contacting those that break the rules, let alone enforcing compliance.
In an open letter published today, the groups warn that hidden clinical trial results have “significant potential to harm European patients, taxpayers and public health”.
“Civil society engagement with multiple trial sponsors across several countries clearly shows that many sponsors continue to be unaware of their obligation to make trial results public,” the letter notes, calling for all regulators to take basic steps to improve transparency, such as notifying companies and institutions about their missing results.
Taking the proposed steps “would require only minimal resources, but would generate substantial benefits” for patients, the groups argue, pointing out that each of the proposed measures is already being successfully implemented by some regulators, demonstrating their feasibility.
According to the EU Trials Tracker, 4,046 out of 13,563 European drug trials (nearly 30%) are currently missing results, in clear violation of transparency rules that require results to be made public within a year of completing a trial.
For example, the University of Amsterdam alone has run 195 drug trials, but has only marked 14 of those trial as completed – and posted results for none of them. It is unclear whether CCMO, the responsible Dutch regulator, has ever contacted the university about these violations.
Regulatory inaction also appears to be the norm in other countries, including Germany, France, Italy and Spain. In late 2019, the European Medicines Agency released data showing that in those four countries alone, results were missing for over 500 applications linked to drug trials involving children.
In contrast, regulators in Austria and Denmark have taken a far more proactive approach, leading to significant improvements in trial reporting in those countries. Across the Atlantic, the U.S. regulator now appears to be preparing to impose fines of over $10,000 for every day that trial results are not reported.
Previous research by TranspariMED suggests that unless national regulators in Europe rapidly take decisive action, the results of many Covid trials – many of which are obliged to publish their results this year – may be lost forever, leaving doctors worldwide uncertain about how to best treat patients suffering from Covid.
Dr Karla Soares-Weiser, Editor in Chief of The Cochrane Library, said:
“Cochrane strongly supports efforts to ensure that data from all clinical trials are available and encourages HMA to take action on these recommendations. Without access to reliable information from all clinical trials, the evidence base on which to make judgements is incomplete – this limits the scientific community’s ability to learn from research findings and can lead to patients being harmed.”
Bettina Ryll, founder of Melanoma Patient Network Europe, said:
"The knowledge that was gained thanks to patients risking their lives in clinical trials should be made accessible to everyone as rapidly as possible to ensure that medical progress is fast and efficient, and that all efforts are made to protect future patients. Sadly, that is often still not the case. Regulators must stop turning a blind eye to this."
Till Bruckner, founder of TranspariMED, said:
"Across Europe, the results of thousands of drug trials are being made public late or not at all while national medicines regulators turn a blind eye. The status quo is completely unacceptable. Regulators should immediately act to protect patients and ensure that all trial sponsors understand and follow the rules."
The full letter can be accessed below.
The letter has been signed by the following 18 groups:
Access to Medicines Ireland
France Assos Santé
France Lymphome Espoir
Health Action International
International Society of Drug Bulletins
Melanoma Patient Network Europe
Salud por Derecho
Transparency International France
Transparency International Global Health