Comments on: OpenTrialsFDA: Unlocking the trove of clinical trial data in Drugs@FDA
https://opentrials.net/2016/08/10/opentrialsfda-unlocking-the-trove-of-clinical-trial-data-in-drugsfda/
All the Data, on All the Trials, LinkedSun, 27 Nov 2016 16:39:37 +0000hourly1https://wordpress.org/?v=4.9.8By: Jocelyne St-Arnaud
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10 Sep 2016 23:37:55 +0000http://opentrials.okfn.org/?p=259#comment-770It is well known that clinical research journals do not publish negative results.
]]>By: Donald W. Light
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 +0000http://opentrials.okfn.org/?p=259#comment-762This 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.
]]>By: John H Noble Jr
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 +0000http://opentrials.okfn.org/?p=259#comment-761Hooray 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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