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Abstract:
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Data from “real world” (RW) practice and utilization in routine clinical care are regarded as a pragmatic source of evidence with high potential to support clinical development and life cycle management of medical products. US and EU regulatory agencies, public-private partnerships and health technology assessment organizations have launched major initiatives to address the concerns and considerations in the use of RW evidence (RWE) to inform regulatory and reimbursement decisions. Recent publications have put forth the challenges and presented potential scenarios where RWE may be considered as part of the evidence package in support of regulatory decisions and fulfil the evidence needs for payers, providers, and patients. However, many challenges remain, from the quality of the data to the appropriate application of research methods to translate RW data (RWD) to robust RWE. As statisticians and quantitative scientists, these are the areas in the RWE research and application that we could provide significant contributions. In this talk, we will specifically focus on the principles and approaches for the evaluation of fit-for-purpose data sources applying quantitative approaches.
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