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

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 United States law was suboptimal and varied widely among companies.
Design: We performed a re-assessment 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 compliance with FDAAA disclosure requirements was notably higher than reported by Miller et al. Among trials subject to FDAAA, Miller et al. reported that, per drug, a median of 67% (middle 50% range: 0–100%) of trials were full...