The International Committee of Medical Journal Editors, which represents such prestigious publications as The Lancet, the Journal of the American Medical Association and the New England Journal of Medicine, has reiterated calls for a clinical trial, which would increase transparency.
Last September, the ICMJE said it would stop publishing trial results unless the data were included on a public database [[10/09/04b]], saying that a registry is the best way to thank the thousands of trial participants who “deserve to know that the information that accrues from their altruism is part of the public record, where it is available to guide decisions about patient care, and deserve to know that decisions about their care rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish.”
The ICMJE notes that it is moving closer to its goal but, as the July 1 deadline for trial registration fast approaches, it has provided the answers to many of the questions it feels trial authors and sponsors are asking, so that they understand the requirements. It has produced a list of 20 standard trial disclosures, including the medical condition being studied, who is funding the research, and the total number of subjects the investigators plan to enroll. The purpose of a clinical trials registry, the committee says, “is to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making.”
Each journal editor will decide on a case-by-case basis about reviewing unregistered trials in this category, but authors whose trial is unregistered will have to convince the editor that they had a sound rationale when they decided not to register their trial. The ICMJE will maintain this policy for the next two years before conducting a review.
The issue of disclosing clinical trial data was thrust into the spotlight last summer after New York Attorney General, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline, alleging that the UK behemoth had suppressed negative results showing its antidepressant Paxil (paroxetine) was linked to an increased risk of suicidal thoughts and acts in children and adolescents [[03/06/04a]]. The global pharmaceutical industry has pledged to set up a worldwide clinical trials register in a bid to reassure patients about drug safety in the wake of the furore that has arisen over the issue [[07/01/05a]], while certain individual pharmaceutical companies have already established their own databases [[02/09/04a]], [[06/09/04e]], [[10/02/05d]], [[04/08/04b]], [[24/01/05a]].
