Are Dutch universities the least transparent trial sponsors in Europe?
Dutch universities have a terrible track record of making their clinical trial results public, a new report on the 23 institutions running the largest number of drug trials in the country shows.
ERRATUM 21 August: The previous version of this blog, and the report itself, incorrectly stated that the Dutch Medicines Evaluation Board is “ultimately responsible for safeguarding the quality of trial data from the Netherlands on the European register". In fact, the responsible agency is the Central Committee on Research Involving Human Subjects (CCMO). TranspariMED apologises for this mistake. The blog below has been corrected accordingly.
An estimated 783 clinical trials run by major Dutch sponsors are missing results on the European trial register, in violation of long-standing EU transparency rules. Most those trials were conducted by universities. Radboud Universiteit alone has failed to upload over 100 trial results. Under European rules, universities – not individual researchers – are responsible for ensuring that trial results are uploaded.
Across the entire country, the results of only 21 clinical trials have been made public as required.
The resulting gaps in the medical evidence base pose a threat to public health because they make it difficult to determine how safe and effective medicines are.
Data provided on the register by Dutch sponsors were so riddled with inaccuracies that TranspariMED and Health Action International, which jointly published the report today, were forced to calculate estimates to gain a clearer picture of the situation.
In particular, many Dutch trials that started over a decade ago were still falsely marked as ongoing, making it extremely difficult for patients to find trials to enrol in. Out of the 1,609 trials covered by the report, only 93 were marked as having been completed more than a year ago – and only 21 of those had results available.
For example, with one exception, all clinical trials that Radboud Universiteit launched in 2006 are still marked as 'ongoing' on the register.
The new data show that the Netherlands are far behind other European countries – and the country does not seem to be making any progress.
In recent years, universities in Ireland and the UK have reported the results of nearly all of their due clinical trials, and universities across Germany and Austria are currently rapidly improving their performance, as are leading institutions in Italy and Spain. The data do not indicate any signs of progress in the Netherlands.
UPDATE 21 August: Data suggest that Radboud University started clearing its backlog of unreported clinical trials in late 2019. While the university's work is still at an early stage, this is a highly encouraging development.
To see how your local university performs on clinical trial reporting,
type its name into the search window of the EU Trials Tracker.
Similarly, while regulators in other European countries have improved the quality of clinical trial data by updating the completion status of clinical trials, the data do not indicate any progress being made by responsible Dutch agency, the Central Committee on Research Involving Human Subjects (CCMO), in this regard.
Till Bruckner, founder of TranspariMED, said:
“Dutch universities’ failure to make clinical trial results public in line with long-standing transparency requirements endangers public health, betrays the trust of the volunteers who participated in these trials, falls short of scientific best practices, and puts millions of Euros in public research funding at risk of being wasted.”
“Why is the Central Committee on Research Involving Human Subjects (CCMO) turning a blind eye to public institutions that flout the rules? Why should Dutch taxpayers keep funding studies if there is no guarantee that their results will rapidly be made public?”
“Clinical trials can cost millions of Euros to run, while uploading their results only takes a couple of days. Other European countries have clearly demonstrated that this problem can be solved at low cost. Dutch patients and taxpayers deserve more respect.”
"TranspariMED will be tracking Dutch universities' trial reporting over the coming months and publish follow-on reports to document their progress over time."
Jaume Vidal, Senior Policy Advisor at Health Action International, said:
“As demonstrated by the quest for a vaccine for Covid-19, clinical trials are a fundamental part in the process of developing and assessing the effectiveness and safety of new medicines. Reporting the results of clinical trials, whether positive or negative, contributes to advances in research and inspires trust in the efficacy of marketed drugs.”
“It is a matter of concern that so many clinical trials results are not adequately reported in the Netherlands. We urge public and private sponsors, as well as the research community and relevant authorities, to comply with European Union regulations and World Health Organization guidelines, in order to, above all else, ensure patient safety.”
Please click on the image below to access the full report.
TranspariMED has a long track record of constructive engagement with universities to help them to improve their trial reporting. Dutch universities are encouraged to use TranspariMED’s collection of transparency tools, and are welcome to contact TranspariMED if they want to exchange experiences with other European universities that are already working to fix the problem.