Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States.

ABSTRACT:

Objective

To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies.

Design

We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid.

Data sources

Information from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors.

Main outcome measures

Compliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA).

Results

Industry co

SUBMITTER: Lassman SM 

PROVIDER: S-EPMC5623439 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature