GSK Calls For Change To Medical Journal Prior-Publication Policies
This article was originally published in The Pink Sheet Daily
Executive Summary
GlaxoSmithKline has created an online clinical trial registry despite comments that such registries discourage publication of data under journal publication restrictions.
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GlaxoSmithKline is urging medical journals to modify their policies regarding prior publication of clinical trial data. In a comment printed in the May 20 edition of The Lancet, GSK execs call for an adjustment to policies that may discourage the publication of data initially appearing online. "We would urge medical journals to ensure that their prior-publication policies do not unduly restrict researchers who wish to put research results online in a timely fashion," GSK Senior VP-Biomedical Data Sciences Frank Rockhold said May 24. The International Committee of Medical Journal Editors requires that companies register their clinical trials as a condition of consideration for publication, a requirement which GSK claims often leads to the disclosure of clinical trial results (1 (Also see "Medical Journals To Require Registration Of All Controlled Trials On ClinicalTrials.gov" - Pink Sheet, 8 Sep, 2004.)). Companies may hesitate to post data online because "some editors consider merely the posting of clinical trial data to an online repository as an action on our part that may jeopardize the opportunity to have the trial subsequently reported in their journals," Rockholder and GSK Chief Medical Officer Ronald Krall write in The Lancet. "We must emphasize that the register is intended to support, not supplant, the scientific discourse that only publication in the usual sense of that term can provide," Rockholder and Krall state. GSK has created a clinical trial registry to provide public access to summaries of roughly 2,600 of the firm's clinical trials of 52 pharmaceuticals and vaccines. "We, like other sponsors, confront a growing expectation that we disclose clinical trial data promptly," Rockholder and Krall note. Roche has also moved forward with clinical trial publication on its website, providing access over the past year to more than 300 protocol and result summaries, the firm announced May 19. -Mary Bruce |