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NICE joins campaign for full disclosure of clinical trial data

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1269 (Published 25 February 2013) Cite this as: BMJ 2013;346:f1269
  1. Matthew Limb
  1. 1London

The UK National Institute for Health and Clinical Excellence (NICE) is supporting a campaign backed by the BMJ to promote openness in reporting of clinical trials.

NICE signed the AllTrials campaign’s petition (alltrials.net) on 19 February, joining a host of leading medical bodies and charities, as the number of signatories rose above 30 000.

NICE’s chairman, Michael Rawlins, said, “We strongly believe that all clinical trial data should be made available so that that those with responsibility for developing clinical guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.”

The AllTrials campaign was launched in January by the BMJ, Bad Science author Ben Goldacre, the charity Sense About Science, the James Lind Alliance, and Oxford University’s Centre for Evidence-based Medicine.1 It calls on responsible bodies to ensure that all trials, past and present, for all treatments, are registered and that the full methods and full results are published.

Supporters of the campaign say that despite years of commitments to openness on clinical trial results, governments, regulators, and research bodies have failed to take decisive action that would benefit patients, researchers, pharmacists, doctors, and regulators everywhere.

Signatories of the petition now include the Royal Society of Medicine, Rethink Mental Illness, Cystic Fibrosis Unite, Muscular Dystrophy Campaign, the Migraine Trust, Parkinson’s UK, the British Pharmacological Society, and the drug company GlaxoSmithKline.2

Thousands of clinical trials have not reported their results; some have not even been registered.

Campaigners believe that under-reporting is a type of research misconduct that leads to overestimation of the benefits of drugs and underestimation of their harmful effects. Because of this, it puts patients at risk and wastes healthcare resources.

Under-reporting is found in academic and non-commercial trials as well as in trials sponsored by the drug and devices industries.

Notes

Cite this as: BMJ 2013;346:f1269

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