Real-world data (RWD) and real-world evidence (RWE) play significant roles in medical product development and regulatory decision-making. RWD consists of information about patient health and healthcare delivery collected from electronic health records, claims data, and disease registries. This data differs from that gathered in specialized research settings. RWE, derived from analyzing RWD, provides insights into a medical product’s usage, benefits, and risks.
Generating RWE involves various study designs, including non-interventional and interventional RWD trials. Recently, there’s been increasing interest in using RWE for pre-market regulatory decisions, such as evaluating medical product effectiveness and risk-benefit analysis. However, challenges exist, such as ensuring the suitability and reliability of RWD, particularly from routine-care settings, and maintaining patient privacy while allowing regulatory access to data.
The FDA has issued guidance on using RWE for regulatory decisions, especially regarding medical devices and assessing drug and biological product registries. They emphasize the importance of data quality, study design, and analysis methods. Collaborations among stakeholders, including regulators, industry, academia, and the clinical research community, are crucial for advancing RWD and RWE applications.
The FDA supports research projects to improve RWD and RWE quality and is involved in initiatives to promote awareness and consistency in reviewing submissions containing RWD. Their Information Technology Strategy for FY 2024-2027 includes enabling advanced data analytics with RWD. In 2024, a broader focus is expected across the U.S. Health and Human Services agencies on RWE, including post-market and health policy contexts.
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[Source: FDA, December 21st, 2023]