Transparency measures. We examine three outcome measures for the trials. The first pertains to trial registration: we determine whether trials are registered within a reasonable timeframe. Second, we determine whether results are reported in a public registry or published in a journal indexed by PubMed, Google Scholar or EMBASE within a reasonable timeframe. Third, we examine FDAAA implementation—that is, whether applicable trials are registered within 21 days of their start date and results reported within 30 days of initial FDA approval of each product or 1 year of the primary completion date, as required by US laws.

Data sharing measures. We examine companies’ data sharing practices and governance structure using five measures: (1) whether they have a public policy committing to sharing analysis-ready datasets and clinical study reports (CSRs) for applicable studies; (2) whether their policy explains how such data can be requested; (3) whether the policy commits to making data available by 6 months after approval by the FDA or European Medicines Agency or 18 months after a trial’s completion date, whichever was later; (4) whether the company reports the number of data requests received and how each was handled (granted or denied); and (5) the proportion of ‘data sharing applicable’ trials registered in a public registry. The overall data sharing score for each company or institution is the average of the five component scores.

Scoring companies on their overall transparency. Each component is weighted equally because each is essential to achieving the full benefits of transparency. All sponsors, public and private, are held to the same standards.

More information on select pieces of the methodology for each reporting year is available below.