Image: Tdorante10 [CC BY-SA 4.0], via Wikimedia Commons
Study flags France, Norway and Poland, while pointing to Romania as proportionally the worst offender
Just three countries—France, Norway and Poland—are responsible for two-thirds of the study protocols that are missing from the EU’s clinical trials register, a study has found.
Under EU rules, sponsors of clinical trials designed to test medical treatments in humans must submit a protocol setting out that design for each country in which people are expected to participate in the trial.
Of just over 31,000 trial protocols that should have been logged in the register, almost 27,000 (86.5 per cent) had been uploaded, the researchers—Nicholas DeVito and Ben Goldacre, from the University of Oxford in the UK—reported in the journal Clinical Trials on 11 February.
Among the 30 countries analysed, 22 had made more than 90 per cent of their expected protocols available, but in Romania, the share was just 17 per cent—the smallest proportion, once countries too small to analyse (Cyprus, Liechtenstein, Luxembourg and Malta) had been excluded. In Norway, the share was only 45 per cent, and in France, it was 49 per cent.
Due in part to the large number of trials conducted within their borders, France, Norway and Poland were responsible for 66 per cent of the missing protocols, with Poland making 61 per cent of the expected protocols available.
DeVito and Goldacre said that the incompleteness of the register and other issues “frustrate efforts to use the [register] as a canonical data source for trial information”.
Role of regulators
Sponsors are supposed to submit their protocols to national regulators, who came under fire from the researchers for not doing more to ensure that protocols are uploaded.
“When regulators cannot ensure the most basic of required record-keeping tasks are completed, it undermines trust in their authority and confidence that due diligence of regulated research is being performed,” their report said.
Research Professional News contacted the regulators of France, Norway, Poland and Romania for comment. By the time this article was published, only the Norwegian regulator had provided a response.
A spokesperson for the Norwegian Medicines Agency said that it “supports the principles and the intentions” of the EU rules, but that “publication of study results is the main responsibility of the [trial] sponsor”.
They said the agency “found it justifiable” to wait for new EU clinical trial rules, including a new reporting system, to come online in 2022 instead of implementing new processes to chase sponsors under the old system.
In addition, they claimed that “the total number of not-reported trials are low compared to the total number of clinical trial applications”.