COMMONS

Chair comments on reported compliance failures in clinical trials

13 September 2018

According to new research published in today’s BMJ, half of European clinical trials have failed to comply with EU rules on reporting results. The report by lead author Dr Ben Goldacre, Director of the DataLab at the University of Oxford, found that 49% of clinical trials on the EU register have not reported results, breaching EU clinical trial guidelines that require results to be reported within 12 months of the trial coming to an end.

Norman Lamb MP, Chair of the House of Commons Science and Technology Committee, said:

“Failing to report results from clinical trials distorts the evidence base.  Doctors, clinicians and even Government Ministers rely on published evidence to make sound decisions in the public interest. Non-publication of results means that time and public money invested in the research is wasted, and risks crucial health-related decisions being made without access to all the facts.

“The variation in compliance rates from university to university is very troubling, not least as the importance of clinical trials transparency has been discussed at the highest levels for years now. Some universities are taking this seriously and are clearly checking to make sure that the trials they are involved with publish results, but far too many have a poor record by this measure.

“I’m pleased to see this data being published, as it identifies which universities need to get their house in order on this and which are doing well. My Committee intends to publish a report on this subject in October, and this work is a very helpful contribution towards that.”

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