Decisions by regulators and clinicians on whether to approve and use new medications are typically based on findings from pivotal clinical trials. For most newer medicines, an industry sponsor drives the early generation of the evidence base supporting the medicine, but this process requires access to and facilitation by global healthcare systems. Data from early clinical trials remain the centerpiece of safety and efficacy assessments, at least until postmarketing data can reach maturity. Transparent sharing of individual participant data (IPD) from clinical trials facilitates enrichment of the postapproval evidence base through novel secondary analyses and informs the design of future studies.

In 2010, the European Medicines Agency began adopting forward-looking policies that promote clinical trial data sharing at the time of market authorization. In 2014, the pharmaceutical industry, via the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), acknowledged the importance of IPD sharing and endorsed a commitment to sharing anonymized IPD for approved medicines upon request by qualified researchers. A 2018 audit reported that data from only 15% of clinical trials were available for sharing 2 years after publication of the primary outcome, with no sharing occurring for oncology trials. Since 2018, there has been substantial development of resources and systems to facilitate r