Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation

Ashley M. Hopkins, Natansh D. Modi, Frank W. Rockhold, Tammy Hoffmann, Bradley D. Menz, Areti-Angeliki Veroniki, Ross A. McKinnon, Andrew Rowland, Sandra M. Swain, Joseph S. Ross, Michael J. Sorich

Research output: Contribution to journalArticlepeer-review

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Abstract

Objectives: Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor. 

Study Design and Setting: This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors’ data sharing policies. 

Results: There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor. 

Conclusion: CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.

Original languageEnglish
Article number111263
Number of pages9
JournalJournal of Clinical Epidemiology
Volume167
Early online date12 Jan 2024
DOIs
Publication statusPublished - Mar 2024

Keywords

  • Blockbuster medicines
  • Clinical study reports
  • Clinical trial transparency
  • Data sharing
  • Data transparency
  • Industry sponsored trials
  • Pharmaceutical industry
  • Regulatory decision transparency

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