“Real World Data and Evidence: An Interdisciplinary Approach and Applications to Precision Medicine and Healthcare”
Abstract: Real world data (RWD) and real world evidence (RWE) have been increasingly used in health care decision-making since the passage of the 21st Century Cures Act on December 9, 2016, which requires FDA to develop a framework and guidance for evaluating real world data (RWD) and real world evidence (RWE) to support approvals of new drugs or devices, or new indications for previously approved drugs, and to support post-approval studies for monitoring safety and adverse events for further regulatory decision-making. Whereas pharmaceutical companies use RWD and RWE to support clinical development activities and to seek evidence to inform health technology assessment (HTA) decisions, the healthcare community uses RWD and RWE to develop guidelines and decisions to support medical practice and to assess treatment patterns, costs and outcomes of interventions. Although high-speed computing tools and machine learning algorithms have been conveniently applied to RWD, there are still substantial challenges in deriving RWE from RWD and in using the RWE in healthcare decision-making. This presentation aims to provide an overview of applications where RWD/RWE plays critical roles in precision medicine and healthcare decision-making during product development, regulatory approval, and healthcare delivery. Case studies are given throughout the presentation.
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