Enhancing patient-level clinical data access to promote evidence-based practice and incentivize therapeutic innovation.

Clinical trials are crucial to determining the human safety and efficacy of new therapeutic innovations. Extraordinary amounts of human experiential data are generated over the course of any clinical trial, however, much of these data is never made publicly accessible. Improved, reliable data sharing is essential to inform clinical decisions and incentivize further therapeutic improvements; this need, and the call and concept to enhance patient-level clinical trial data accessibility is not new. Several recent public and private shifts in clinical data sharing policies and procedures promise to improve access and data utility to reduce waste in research and increase efficiency of evidence synthesis. Nonetheless, pharmaceutical industry remain reluctant to share full clinical data sets at some level to protect their commercial interests and avoid misuse of their data. Here, we review the landscape of emerging regulations related to the sharing of patient level data and current clinical data access models of major pharmaceutical companies. We also summarize the different measures that could satisfy both clinical data producers and users in achieving the benefits of accessing patient-level data while mitigating any associated risks.