Data from: 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 fully
compliant with registration and results reporting requirements. Upon
re-analysis of the data, we found that a median of 100% (middle 50% range:
93–100%) of clinical trials for a particular drug fully complied with the
law. When looking at overall compliance at the trial level, our
re-assessment yields 94% timely registration and 90% timely results
reporting among the 49 eligible trials, and an overall FDAAA compliance
rate of 86%. Conclusions: The claim by Miller et al. that industry
compliance is below legal standards is based on an analysis that relies
upon an incomplete dataset and an interpretation of FDAAA that requires
disclosure of study results for drugs that have not yet been approved for
any indication. Upon re-analysis using a different interpretation of FDAAA
that focuses on whether results were disclosed within 30 days of drug
approval, we found that industry compliance with U.S. statutory disclosure
requirements for the 15 reviewed drugs was consistently high.