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UK clinical trials must be registered to win ethics committee approval

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5614 (Published 16 September 2013) Cite this as: BMJ 2013;347:f5614
  1. Clare Dyer
  1. 1BMJ

Clinical trials in the United Kingdom will have to be registered on a publicly accessible database as a condition of winning approval from ethics committees, under a new rule from the UK Health Research Authority that takes effect on 30 September.

The move is a start on implementing the authority’s action plan to increase transparency in research, set out in a discussion paper last May, which included ensuring that the outcomes of clinical trials are published.1

The authority, which has signed up to the AllTrials campaign on disseminating clinical trial data (alltrials.net), confirmed in July that it would introduce mandatory trial registration as part of a plan to promote greater transparency.

“We are fully committed to the principles of transparency in health research,” said Janet Wisely, the authority’s chief executive. “Including a requirement for registration as a condition of the favourable ethical opinion is a significant step towards this.”

The requirement was welcomed by Tracey Brown, director of the charity Sense About Science and cofounder of the AllTrials campaign. “The HRA has really led the way in its proposals to streamline registration compliance with the ethical approval process that all trials go through,” she said. “Despite the fact that hidden and unregistered trials are compromising patient care and rightly causing public outrage, change is still being blocked and slowed by bodies who say it’s hard to do, complex, and hard to police.

“The HRA’s proposals are clear and effective and give the lie to that. We know that other organisations and regulators around the world are being encouraged by the HRA’s resolute approach to transparency.”

Failure to register would be a breach of good research procedures and managed through the standard procedure for research ethics committees, in line with other breaches, the authority said.

Studies requiring registration from 30 September are clinical trials of an investigational medicinal product; clinical investigations or other studies of a medical device; combined trials of a medicinal product and a device; and other clinical trials to study a novel intervention or randomised trials to compare interventions in clinical practice.

For other categories of study, plans for registration will be asked for and considered by the research ethics committee.

A trial’s sponsor and investigator will be in breach if the study is not registered within six weeks of the requirement of the first patient or, for medical device studies, within the timeline determined by the current registration and publication decision trees. The Health Research Authority intends to bring the requirements for studies of devices in line with those for other clinical trials by March 2014.

A spokesman for the Association of the British Pharmaceutical Industry said, “The ABPI code of practice already requires registration of clinical trials. Additionally, our recently launched clinical trials disclosure toolkit provides tools for companies to help meet their requirements for registration of trials as well as disclosure of summary results.”

Notes

Cite this as: BMJ 2013;347:f5614

References

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