ISPE RWE Task Force (実地根拠に関する特別研究班)

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Considerations in characterizing real-world data relevance and quality for regulatory purposes: A commentary Use of real-world evidence in regulatory decisions for rare diseases in the United States-Current status and future directions Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms The Certainty Framework for assessing real-world data in studies of medical product safety and effectiveness Noelle Cocoros Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials Real-world evidence to support regulatory decision making: New or expanded medical product indications