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Abstract:
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The real-world data and evidence has become a trendy term in many fields, particularly recently in the pharmaceutical industries. In this session, we would like to first discuss the risk of the seemingly promising land on various types of real-world data, such as Electronic Health Record, data collected from wearable electronic devices, and social media. With such understanding, we then discuss strategies, from the statisticians and data scientists’ point of views, that will mitigate the risk for the purposes of scientific discovery, evaluation and validation, and generating evidence for regulatory health authorities. Finally, we would like to simulate scenarios that drugs might be introduced into the real-world without confirmatory studies, how real-world data would fill up the gap to provide convincing safety and efficacy evidence.
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