Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study

Mandatory trial registration, and later results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. The Food and Drug Administration (FDA) Amendments Act (FDAAA) was enacted by Congress on September 27, 2007, requiring the registration of all non-phase I...

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Bibliographic Details
Published in:	Current controlled trials in cardiovascular medicine 2018-10, Vol.19 (1), p.581-581, Article 581
Main Authors:	Zou, Constance X, Becker, Jessica E, Phillips, Adam T, Garritano, James M, Krumholz, Harlan M, Miller, Jennifer E, Ross, Joseph S
Format:	Article
Language:	eng
Subjects:	Analysis Annual reports Central Nervous System Agents - adverse effects Central Nervous System Agents - therapeutic use Clinical trial registration Clinical trial results Clinical trials Clinical Trials as Topic - methods ClinicalTrials.gov Cohort analysis Data Accuracy Dosage and administration Drug Approval Drugs FDA approval FDAAA Humans Mental disorders Mental Disorders - diagnosis Mental Disorders - drug therapy Mental Disorders - physiopathology Mental Disorders - psychology Neuropsychiatry Paroxetine Pharmaceutical industry Publication Bias Registration Registries Research Design Retrospective Studies Selective publication Statistical significance Time Factors Treatment Outcome United States United States Food and Drug Administration
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Summary:	Mandatory trial registration, and later results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. The Food and Drug Administration (FDA) Amendments Act (FDAAA) was enacted by Congress on September 27, 2007, requiring the registration of all non-phase I clinical trials involving FDA-regulated medical interventions and results reporting for approved drugs. The association between FDAAA enactment and the registration, results reporting, and publication bias of neuropsychiatric trials has not been studied. We conducted a retrospective cohort study of all efficacy trials supporting FDA new drug approvals between 2005 to 2014 for neuropsychiatric indications. Trials were categorized as pre- or post-FDAAA based on initiation and/or completion dates. The main outcomes were the proportions of trials registered and reporting results in ClinicalTrials.gov, and the degree of publication bias, estimated using the relative risks pre- and post-FDAAA of both the publication of positive vs non-positive trials, as well as of publication of positive vs non-positive trials without misleading interpretations. Registration and results reporting proportions were compared pre- and post-FDAAA using the two-tailed Fisher exact test, and the degrees of publication bias were compared by calculating the ratio of relative risks (RRR) for each period. The FDA approved 37 new drugs for neuropsychiatric indications between 2005 and 2014 on the basis of 142 efficacy trials, of which 101 were pre-FDAAA and 41 post-FDAAA. Post-FDAAA trials were significantly more likely to be registered (100% vs 64%; p
ISSN:	1745-6215 1745-6215 1468-6694