Clinical trial transparency has emerged in recent years as a key function within pharmaceutical and academic organizations. Although trial transparency is typically associated with protocol registration and results disclosures, regulations and voluntary data sharing processes have led to a sharp increase in clinical trial data and documents now accessible to anyone with an internet connection. In particular, 42 CFR Part 11, which guides public disclosure of clinical information on ClinicalTrials.gov, as well as global regulatory changes to marketing authorization applications in Europe and Canada, such as European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI), require sponsors to provide clinical documents that were previously not available to the general public. This evolution is a win for advocates of informed decision-making but poses operational and functional challenges in managing policy changes and different expectations between agencies. Sponsors preparing to share their clinical documents can incorporate best practices and implementation recommendations presented in this white paper, including the importance of planning and basic data anonymization strategies for protecting patient privacy while balancing data utility.
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Driving development of drug products from pre-IND through marketing.