miércoles, 22 de enero de 2014
Si tú me dices Ben...lo creo todo: "Improving, and auditing, access to clinical trial results"
Authors: Ben Goldacre, Wellcome research fellow in epidemiology, Carl Heneghan, professor
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. Iain Chalmers described in 2006 how progress in the 1990s soon deteriorated into broken promises. 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, which most UK medical and academic professional bodies signed up to, falsely claimed that a “robust regulatory framework” ensures access to trial results. US legislation requiring all results to be posted on clinicaltrials.gov within 12 months of completion has been widely ignored, with no enforcement. There has also been covert activity from industry—a leaked memo on its “advocacy” strategy included “mobilising patient groups” to campaign against transparency.
Despite this, we have achieved considerable progress. The AllTrials.net campaign,
started 12 months ago, calls for all trials on all uses of all currently prescribed treatments to be registered, with their full methods and results reported. It now has the support of most medical and academic professional bodies as well as the National Institute for Health and Care Excellence (NICE), Medical Research Council, Wellcome, more than 130 patient groups, 60 000 members of the public, and many in industry including GlaxoSmithKline. The Health Research Authority has announced that registration will be a condition of ethics committee approval. The BMA has passed a motion stating that withholding trial results is research misconduct, and the General Medical Council is re-examining its guidance on the matter. (Más)
Por todo esto...Ben: