https://opentrials.net/2016/08/10/opentrialsfda-unlocking-the-trove-of-clinical-trial-data-in-drugsfda/ All the Data, on All the Trials, Linked Sun, 27 Nov 2016 16:39:37 +0000 hourly 1 https://wordpress.org/?v=4.9.8 https://opentrials.net/2016/08/10/opentrialsfda-unlocking-the-trove-of-clinical-trial-data-in-drugsfda/#comment-770 Sat, 10 Sep 2016 23:37:55 +0000 http://opentrials.okfn.org/?p=259#comment-770 It is well known that clinical research journals do not publish negative results.

]]> https://opentrials.net/2016/08/10/opentrialsfda-unlocking-the-trove-of-clinical-trial-data-in-drugsfda/#comment-762 Fri, 09 Sep 2016 13:32:09 +0000 http://opentrials.okfn.org/?p=259#comment-762 This valuable work adds to evidence that many but not all medical journals legitimate partial and selected evidence as received medical knowledge about drugs, guidelines, and clinical protocols.

]]> https://opentrials.net/2016/08/10/opentrialsfda-unlocking-the-trove-of-clinical-trial-data-in-drugsfda/#comment-761 Fri, 09 Sep 2016 13:12:39 +0000 http://opentrials.okfn.org/?p=259#comment-761 Hooray for OpenTrials. Its results in comparing the journal version of antidepressant trials with FDA information makes the case for a change of law that would require “truth in research labeling” to guide medical journal editors and their peer reviewers. All journal reports should make known whether the authors are reporting trial results in terms of the original a priori protocol submitted to the FDA for marketing approval or some post hoc departure from the original protocol. Knowing which is which would facilitate journal peer review and editor decision making. A petition to the US Congress with proposed language for amending Section 801 of the Public Health Service Act to require the FDA and NIH to coordinate in certifying that trial content submitted by responsible parties to the FDA and to ClinicalTrials.gov are identical. Journal editors could then require authors to disclose that manuscripts submitted for publication are reporting results according to the FDA protocol or not. Peer reviewers and readers of published reports based on post hoc changes in the trial content submitted to the FDA could then check for disparities in reported results. The petition to the US Congress with the proposed amendment of Section 801 of the Public Health Service Act has been submitted to the FDA in response to call for public comments on its recommendation for the sixth reauthorization of the Prescription Drug User Fee Act: http://www.regulations.gov/#!documentDetail;D=FDA-2016-N-1895-0003.

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