More than half of EU clinical trials do not comply with rules

A study has shown that half of clinical trials on the EU register have not reported results, despite rules that require results to be posted within 12 months of study completion.

A team of researchers led by Dr Ben Goldacre at the University of Oxford, have found that although compliance with EU rules has been poor overall, trials with commercial sponsors are substantially more likely to have posted results than trials with non-commercial sponsors. This means that universities, hospitals, governments and charities are less likely to provide results within 12 months of the completion of the study.

The study also shows that EU registry data commonly contains inconsistencies that might prevent regulators assessing compliance.

The researchers investigated the compliance of clinical trials with the European Commission ruling that results should be published within 12 months. They explored factors associated with non-compliance, and ranked sponsors by compliance, making a website in the process where an ongoing audit can be assessed.

Dr Goldacre’s team found that only 49.5 percent, from the 7,274 results that were required, were actually reported. 

Researchers found that recent trials were more likely to report their results than older trials, and studies with a commercial sponsor were far more likely to report results – 68 percent, opposed to 11 percent of trials with a non-commercial sponsor.

Sponsors conducting a large number of trials were also more likely to report results (78 percent, compared with 18 percent). 

During the study, researchers found a number of errors in many of the reported results, with 29.4 percent of trials marked ‘completed’ without a listed completion date. 

It is paramount that the results of clinical trials are reported correctly and on time, as they are known to be used by clinicians, patients and policy makers, to help them make informed choices about which treatments work the best.

The researchers also discuss the development of the EU TrialsTracker website, which gives detailed information on the trial reporting performance of every drug company, hospital and university conducting clinical trials in Europe.

Detailed information is provided about the sponsors that are the best or worst at complying with the law, giving detailed information on the individual trials that have failed to report results.

"To our knowledge this is the first study of compliance with European Commission requirements on trial reporting," said the researchers.

"We have found strong evidence that the European Commission guideline, requiring all trials’ results to be reported on EUCTR within 12 months of completion, is commonly being breached. Sponsors doing fewer trials, and non-commercial sponsors such as universities, have particularly low reporting rates."

The study was published by the British Medical Journal.

-----------------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.