Editorials

Improving, and auditing, access to clinical trial results

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g213 (Published 15 January 2014) Cite this as: BMJ 2014;348:g213

This article has a correction. Please see:

  1. Ben Goldacre, Wellcome research fellow in epidemiology1,
  2. Carl Heneghan, professor2
  1. 1London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK
  2. 2Centre for Evidence Based Medicine, Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  1. ben.goldacre{at}lshtm.ac.uk

All trials should be registered, with their full methods and results reported, and routine audit on the extent of information withheld

The House of Commons Public Accounts Committee delivered a remarkable report on 3 January. Its initial remit was the United Kingdom’s £424m (€510m; $697m) stockpile of oseltamivir (Tamiflu), but the committee soon broadened out—with evident surprise—into the ongoing problem of clinical trial results being routinely and legally withheld from doctors, researchers, and patients.

This situation has persisted for too long. The first quantitative evidence on publication bias was published in 1986.1 Iain Chalmers described in 2006 how progress in the 1990s soon deteriorated into broken promises.2 Recent years have seen extensive denial. The Association of the British Pharmaceutical Industry (ABPI) has claimed that these problems are historic, and that results are now posted on clinicaltrials.gov. The recently defunct Ethical Standards in Health and Life Sciences Group,3 which most UK medical and academic professional bodies signed up to, falsely claimed that a “robust regulatory framework” ensures access to trial results.4 US legislation requiring all results to be posted on clinicaltrials.gov within 12 months of completion has been widely ignored,5 with no enforcement. There has also been covert activity from industry—a leaked memo on its “advocacy” strategy included “mobilising patient groups” to campaign …

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