A coalition of 21 European health and patient groups today called on medical research institutions across the continent to make the results of their clinical trials public.
Letters sent to 56 major institutions – most of them universities and hospitals – flag their current weak performance, and ask them to explain what steps they are taking to clear their backlogs of missing trial results.
Together, these institutions are responsible for at least 931 trials that are missing results on the European database, in violation of EU transparency rules adopted to protect patient interests.
The letters, which are signed by 21 groups from eleven different countries, note that:
“Failure to upload clinical trial results onto trial registries is not a victimless crime. It harms patients, undermines public health, slows down medical progress, and increases the risk of precious medical research funding being wasted.”
“Both European Union rules and World Health Organisation best practices state that publication of trial outcomes in academic journals is not an acceptable substitute for uploading trial outcomes onto registries. Posting results onto registries accelerates medical progress, minimises the risk of a trial never reporting its results, and typically improves the reporting of patient-relevant outcomes.”
According to the European Medicines Agency, the results for nearly 6,000 trials – including hundreds of trials involving children – are currently missing from its database.
A recent TranspariMED report found that over half of Covid drug trials currently underway in Europe are being run by companies and institutions that are in breach of transparency requirements.
Each of the 56 institutions contacted today has run at least fifty drug trials, and has failed to report results for at least 20% of its verifiably due trials.
The true number of missing trial results they are jointly responsible for is almost certainly far higher than 931 because many of their completed trials are still falsely marked as ‘ongoing’ in the database.
The European Medicines Agency has recently made its database significantly more user friendly, and has repeatedly reminded institutions that uploading the results of their clinical trials is obligatory.
Responsibility for enforcing transparency rules lies at the national level. To date, only Denmark’s national medicines regulator is effectively enforcing transparency requirements.
While some major institutions have already begun to clear their backlogs of unreported trials, many others have still not uploaded a single trial result to the EudraCT database, prompting calls to cut off their funding.
Till Bruckner, founder of TranspariMED, said:
“Today’s letter sends a loud and clear message to universities and hospitals that their patients expect them to play by the rules. Medical research only benefits society if results are made public. Much of the research run by these institutions is funded by public money, and all of it involves people who volunteered to participate in clinical trials to help scientists to find more effective treatments and cures. Neglecting to make trial results public is deeply unethical because it betrays the trust of patients, wastes taxpayers’ money, and endangers public health.”
“More broadly, we need to ask why it is left to nonprofit groups to remind universities and hospitals of long-standing regulatory requirements. Why are national medicines regulators not cracking down? Why do national funding agencies continue giving public money to institutions that act unethically and waste public funds? Voluntary compliance has clearly failed. National governments across Europe urgently need to put an end to this impunity and start imposing sanctions on institutions that put patients at risk.
The letters sent out today are signed by groups from eleven countries: Belgium, Denmark, Greece, France, Germany, Ireland, Italy, the Netherlands, Spain, Switzerland, and the UK.
In alphabetical order:
Access to Medicines Ireland
Asociación por un Acceso Justo a los Medicamentos
Consumer Association the Quality of Life – EKPIZO
European AIDS Treatment Group
Groupe sida Genève
Institute for Scientific Freedom
Observatoire Transparence Médicaments
PEAH - Policies for Equitable Access to Health
Salud por Derecho
Stichting Farma ter Verantwoording
Test Aankoop / Test Achats
Transparency International Health
Universities Allied for Essential Medicines Europe
TranspariMED has compiled a collection of transparency tools for universities and hospitals that wish to improve their clinical trial reporting performance.