Dutch universities violate clinical trial transparency rules on a large scale

31 Oct 2019

Dutch universities violate clinical trial transparency rules on a large scale, new data gathered by Universities Allied for Essential Medicines (UAEM) and Health Action International shows.

 

Dutch universities have sponsored 1,140 clinical trials, but have posted results for only two (!) of these trials. 

 

Furthermore, only 25 of the 1,140 clinical trials are listed on the European trial registry as due to post results. This is an implausibly low number, and indicates that the Dutch medicines regulator CCMO has failed to keep registry data up to date.

 

 Source: "Registratieplicht klinischetrials massaal ontdoken", Medisch Kontakt, 31 Oct 2019

 

 

Edwin Duijzer of UAEM said:

 

"This lack of transparency of research results means that doctors and patients do not have all the information about the effect and safety of a given medicine, with potentially serious consequences for patients’ health.

 

This is a disappointing score for Dutch universities and is in stark contrast to, for example, the United Kingdom, where some universities currently score as high as 94%."

 

 

Analyis: Are over 99% of Dutch university trials missing results?

 

Analysis by TranspariMED: The (already very low) 8% reporting rate stated in the table above significantly overestimates the true reporting rate. Assuming conservatively that half of the 1,140 Dutch university trials ended more than a year ago, and are thus due to post results, suggests an actual reporting rate of less than 0.18%.

 

In other words, over 99% of due clinical trials run by Dutch universities are likely missing results on the European trial registry, in violation of EU transparency rules.

 

Till Bruckner, founder of TranspariMED, said:

 

"Dutch universities may have the lowest clinical trial reporting performance in the whole of Europe. Their failure to fully report clinical trial results harms Dutch patients and taxpayers. The strong performance of leading academic institutions in the UK shows that Dutch universities can - and must - fix this problem."

 

 

 

Note: TranspariMED has not checked the accuracy of the data presented above. However, TranspariMED understands that UAEM and HAI extracted this data from the EU Trials Tracker, which is a reliable source of performance data for trial sponsors in Europe.

 

Universities that want to improve their clinical trial reporting can find a collection of transparency tools, tips and tricks on the TranspariMED website.

 

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