One of the largest medical research institution in the Netherlands is taking the lead on improving clinical trial transparency, recent monitoring data shows. Radboud university medical center (Radboudumc) is now systematically uploading clinical trial results, setting a powerful example for other Dutch institutions.
With 242 drug trials listed on the European registry, Radboudumc is the largest trial sponsor in the country.
Data show that the center has recently uploaded dozens of trial results onto the European trial registry. It is also actively updating its registry records to add trial completion dates.
Radboudumc’s efforts will benefit patients in the Netherlands, who in the past often had to wait several years until trial results were made public.
INVESTING IN TRANSPARENCY
A Radboudumc spokesperson told TranspariMED that:
“Radboud university medical center has put a lot of effort into completing the data input in the EudraCT register in the past year. Additional funding and capacity has been made available for central support of investigators. With these resources, we drafted a general work instruction and investigators were approached to complete their data.”
“A comparison of the EudraCT register with our own project management system showed that for 209 studies no data were yet known. A quarter of these studies had not yet been completed, or had been completed less than a year ago (status ‘ongoing’, n=49). Therefore for these studies no results are available yet.”
“Meanwhile another quarter (n=54) has been reported as completed via the Competent Authority. Of the majority of these studies, results are available in the EudraCT register, or a draft of it is in preparation in EudraCT.”
“Processing of the remaining studies is ongoing. A challenge here is that in older studies it sometimes turns out to be difficult to get in contact with the investigator, for example because they no longer work at Radboudumc.”
“At Radboud university medical center, we are strongly committed to Open Science and find it important to be transparent about our research data and results. We are happy that we have already made considerable progress, but continue to work hard to catch up completely.”
OTHER DUTCH SPONSORS STILL LAGGING BEHIND
A recent study of the trial reporting performance of Europe’s 26 largest medical research institutions found that Radboudumc was in the top ten both in terms of absolute number of results uploaded and in terms of the percentage of due trials reported.
The same study found that only three of the 26 largest centers have not made visible progress. Two of these negative outliers, the universities of Leiden and Groningen, are based in the Netherlands.
Dutch regulator CCMO has told journalists that it considers the publication of trial results “of vital importance” and has repeatedly reminded them of their obligations, but lacks the power to enforce European transparency guidelines. That will change at the end of January 2022, when the EU Clinical Trial Regulation fully comes into force.
BENEFITS FOR RESEARCHERS AND PATIENTS
Till Bruckner, founder of TranspariMED, said:
“It is fantastic that Radboudumc is setting a positive example and leading the way on transparency. Radboudumc is not only doing the ethically right thing, it is also ensuring that it will be able to continue to receive support for future clinical trials from global funders like the Wellcome Trust, which are increasingly monitoring the trial reporting performance of their grantees.”
“Reporting research results is an integral part of overall research excellence, and it’s wonderful that patients participating in Radboudumc trials can be confident that their contribution will help to develop new treatments and cures.”
Note: Until last month the EU Trials Tracker aggregated data for Radboudumc and Radboud University. These data have now been disaggregated, and the Tracker lists the two sponsors separately. The Tracker data for Radboudumc currently only shows 21 trials as "due with results," additional trials already have results, but their status is still being updated on the EudraCT registry. Radboudumc's visible performance on the Tracker is likely to improve dramatically following the next Tracker update in November.