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ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.

Abstract：

BACKGROUND:Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. PURPOSE:To validate results posted on ClinicalTrials.gov against publicly available U.S. Food and Drug Administration (FDA) reviews on Drugs@FDA. DATA SOURCES:ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical and statistical reviews). STUDY SELECTION:100 parallel-group, randomized trials for new drug approvals (January 2013 to July 2014) with results posted on ClinicalTrials.gov (15 March 2015). DATA EXTRACTION:2 assessors extracted, and another verified, the trial design, primary and secondary outcomes, adverse events, and deaths. RESULTS:Most trials were phase 3 (90%), double-blind (92%), and placebo-controlled (73%) and involved 32 drugs from 24 companies. Of 137 primary outcomes identified from ClinicalTrials.gov, 134 (98%) had corresponding data at Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results. Most differences were nominal (that is, relative difference <10%). Primary outcome results in 14 trials could not be validated. Of 1927 secondary outcomes from ClinicalTrials.gov, Drugs@FDA mentioned 1061 (55%) and included results data for 367 (19%). Of 96 trials with 1 or more serious adverse events in either source, 14 could be compared and 7 had discordant numbers of persons experiencing the adverse events. Of 62 trials with 1 or more deaths in either source, 25 could be compared and 17 were discordant. LIMITATION:Unknown generalizability to uncontrolled or crossover trial results. CONCLUSION:Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half the secondary outcomes, as well as serious events and deaths, could not be validated because Drugs@FDA includes only "key outcomes" for regulatory decision making and frequently includes only adverse event results aggregated across multiple trials. PRIMARY FUNDING SOURCE:National Library of Medicine.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

Schwartz LM,Woloshin S,Zheng E,Tse T,Zarin DA

doi

10.7326/M15-2658

subject

Has Abstract

pub_date

2016-09-20 00:00:00

pages

421-30

issue

eissn

0003-4819

issn

1539-3704

pii

2529054

journal_volume

165

pub_type

杂志文章

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ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.