My BMJ editorial: we need routine audit of missing clinical trials

January 15th, 2014 by Ben Goldacre in alltrials campaign, publication bias, regulating research | No Comments »

I wrote this editorial in the British Medical Journal with the magnificent Carl Heneghan, director of the Centre for Evidence Based Medicine at Oxford. It’s about the Public Accounts Committee, progress on publication bias, and a suggestion for routine ongoing audit to give actionable information for decision-makers on how much information is missing.

Screenshot 2014-01-15 13.43.40… While the current state of secrecy continues, there is much to be done with the most basic research tool in medicine: audit. Industry is quibbling over the precise proportion of trials that go undisclosed. This should not be a matter of debate. We need a trials observatory, covering all trials on all currently used treatments, that matches registry entries and other sources of information on completed trials against sources of results, whether those are in academic papers, clinical study reports, regulatory documents, or online postings. From these data we could derive live dashboards on transparency to drive up best practice, identify the best and worst companies for missing results, the treatments where most information is missing, the best and worst investigators, and more.

This is actionable information. If routine audit shows a particular principal investigator is performing badly, with many unreported results, should ethics committees grant them access to more trial participants? Will patients participate in trials for companies that withhold results? If two treatments have equivalent benefits, but one comes from a company with a track record of transparency and the other from a company that actively undermines the transparency campaign, are those two treatments still equivalent, and which should a cautious clinician prescribe?

You can read the full editorial for free here, or in the paper edition of the BMJ this Friday.

I will be back with more news on auditing missing information shortly. I think you will like it.


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