FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM

What FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM requires

Pursuant to the 21st Century Cures Act, which added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) has created a framework for evaluating the potential use of real-world evidence (RWE). This framework is designed to help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act, or to help support or satisfy drug postapproval study requirements. The framework applies to drugs and biological products but does not cover medical devices. Real-World Data (RWD) are defined as data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, such as electronic health records (EHRs) and medical claims. RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. The core of the FDA's evaluation approach under this framework consists of a three-part assessment for any RWE submission. The considerations are: 1. Whether the RWD are fit for use, which involves assessing data reliability (data accrual and data assurance) and relevance. 2. Whether the trial or study design used to generate RWE can provide adequate scientific evidence to answer the regulatory question. 3. Whether the study conduct meets FDA regulatory requirements, such as for study monitoring and data collection. The FDA's RWE Program is multifaceted, involving demonstration projects, stakeholder engagement, internal processes for senior leadership input, and the development of guidance documents to assist developers.

Pillar: Medical & Healthcare · Authority: Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated: 2018-12-31

Primary source: https://www.fda.gov/media/120060/download

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• Definitions of Real-World Data and Real-World Evidence: Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
• Definitions of Real-World Data and Real-World Evidence: Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.

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