Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration–Approved Anticancer Drugs: A Call for Systematic Data Availability

Organizations including the WHO, Cochrane, International Committee of Medical Journal Editors, European Medicines Agency (EMA), and patient advocacy groups have all argued that providing independent access to clinical study reports (CSRs) and individual participant data (IPD) from clinical trials is important for building trust in drug approval processes, preventing study duplications, and informing the design of future trials.1-4 CSRs, most often associated with industry-sponsored clinical trials, are comprehensive documents that frequently span hundreds of pages to provide detailed aggregate-level insights into clinical trial methodologies and results. IPD, on the other hand, offers in-depth information on each trial participant's demographics, laboratory measurements, adverse events, and responses to treatment, as recorded during each clinical visit. The comprehensive sharing of CSRs and IPD has immense potential to enable the discovery of novel insights through new subgroup and secondary end point analyses, support meta-analyses, and foster a deeper understanding of drug effects.4,5 These are particularly important initiatives for adverse event information on newer drugs and questions that single randomized controlled trials are not statistically powered to answer. Moreover, it should be acknowledged that participants often enroll in clinical trials with the understanding that their involvement, while potentially not personally beneficial, will contribute to advancing future care.6 The responsibility thus falls on all stakeholders to honor this commitment by maximizing the potential for scientific discovery.