Dutch parliamentarian urges improvements in clinical trial reporting – and we apologise for a mistake

21 Aug 2020

Yesterday TranspariMED and Health Action International jointly published a report on clinical trial reporting in the Netherlands that made the front page of a national newspaper.

 

Our report generated a lot of public interest, but also some controversy.

 

Below an overview of developments over the last 24 hours.

 

 

CONTROVERSIES

 

Which Dutch agency is responsible for clinical trial data quality?

 

Our report contained a factual mistake. The Dutch Medicines Evaluation Board clarified that it was not “ultimately responsible for safeguarding the quality of trial data from the Netherlands on the European register,” as the report had erroneously claimed.

 

TranspariMED got this wrong. The Medicines Evaluation Board (MEB) is listed as the National Competent Authority of the Netherlands on the European Medicines Agency website, but it is not responsible for safeguarding the quality of trial data. A different agency, the Central Committee on Research Involving Human Subjects (CCMO), bears responsibility for this in the Netherlands.

 

TranspariMED apologises to the Medicines Evaluation Board, without reservations, for this misrepresentation.

 

How many due trials have reported results?

 

Three universities questioned the data in the report, flagging apparent errors. After carefully reviewing their objections, TranspariMED stands by the original data presented in the report.

 

Please see this statement for a list of the disputed trials and a more detailed discussion.

 

 

REACTIONS TO OUR REPORT

 

Questions from parliament

 

Member of Parliament Liliane Ploumen (PvdA) sent eleven questions about trial reporting to the responsible government minister. One of the questions reads:

 

“Do you believe that the Netherlands, partly because of the location of the European Medicines Agency [in Amsterdam], should lead by example? If so, how are you going to do that?”

 

Radboud University is already working to fix the problem

 

Radboud University provided a list of 13 trials for which it had uploaded results, but which have inconsistent data and therefore do not (yet) qualify as “due and reported” (explainer here). Most of these results were uploaded in late 2019 or 2020. This indicates that Radboud University has already started clearing its backlog of unreported clinical trials. (You can explore Radboud University’s evolving trial portfolio on the EU Trials Tracker.)

 

This is excellent news for Dutch patients and taxpayers.

 

Hopefully, Radboud University’s pioneering efforts will encourage other Dutch institutions to achieve compliance with transparency rules, strengthen their scientific practices, honour the trust of trial participants, and accelerate medical progress.

 

Statement from leading Dutch trial sponsor

 

The company HAL Allergy was highlighted in our report as the only major Dutch trial sponsor that performs strongly on trial reporting. A company representative told newspaper NRC that:

 

“I think we just do what is asked of us. As a pharmaceutical company it is always useful to know what the world is doing around you, that other companies are also working on peanut allergies, for example. But the purpose of such a register is above all that research is not done twice, that money is not wasted on research that previously showed that something does not work.”

 

 

WHAT HAPPENS NEXT?

 

CCMO statement expected

 

Newspaper NRC reports that CCMO, the agency responsible for Dutch data on the European trial registry, said it would provide a detailed response to our report later. TranspariMED will keep you updated on CCMO’s response.

 

Tracking progress

 

Over the coming months and years, TranspariMED and Health Action International will publish regular follow-on reports to track Dutch universities’ progress in clinical trial reporting.

 

 

USEFUL RESOURCES FOR DUTCH UNIVERSITIES

 

eLearning module. Paul Janssen FutureLab Leiden flagged its free eLearning module “Clinical Research Regulation in the Netherlands”. The module explains the role of the CCMO and other agencies and accredited research ethics committees in the Dutch system.

 

Analysis of Dutch ecosystem. Pharmacist Sander van den Bogert shared his 2017 PhD thesis on “Trials & Tribulations: Studies on the fate, transparency and efficiency of clinical drug trials” which includes a chapter on the reporting of clinical drug trials in the Netherlands.

 

Tools. TranspariMED’s collection of transparency tools includes the QUEST trial reporting manual, slides from a QUEST trial reoporting workshop, and other useful resources.

 

Explainers. See also these explainers on why reporting results on trial registries is so important, on why keeping registry data up to date really matters, and how to report the ‘results’ of trials that never recruited any patients.

 

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