KEYWORDS
Health data-sharing, clinical trials, decision-making, informed consent, social alliance.
Introduction
Globally, numerous initiatives are converging on the importance of promoting a participatory clinical research approach. The crux of this movement is to empower clinical trial participants with the access and capability to utilize, their health data, predominantly with a focus on enhancing health data sharing. Such endeavors not only foster informed medical decision-making but also catalyze future research pursuits (1). A prime exemplar of these efforts is the Multi-Regional Clinical Trials Center (mrctcenter.org), dedicated to bolstering the integrity, safety, and vigor of clinical trials on an international scale. This organization draws upon the expertise of multidisciplinary teams from diverse sectors— industry, academia, advocacy groups, non-profit organizations, and regulatory agencies—to address pressing issues in clinical trial conduct and oversight (2). In parallel, TransCelerate BioPharma Inc. (www.transceleratebiopharmainc.com), an industry-wide collaboration, seeks to enhance the efficiency, effectiveness, and quality of new drug delivery. It aspires to develop practical resources that empower sponsors to provide access to and facilitate the return of, participants’ clinical trial data (3).
