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 (9

SUBMITTER: Schwartz LM 

PROVIDER: S-EPMC5028264 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature