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Credits: None available.
The US Food and Drug Administration (FDA) has been charged to explore and use Real Word Data (RWD) through the 21st Century Cures Act (2016) to support the safety and effectiveness evaluation of medical products, including biologics (e.g., vaccines, blood products, and biotherapies). RWD may be described as data relating to patient health status and/or delivery of health care and may be found in Electronic Health Records (EHRs), medical claims, patient registries, among other data sources. RWD-informed benefit-risk assessments have been used for navigating many concerns related to medical interventions during the SARS-CoV-2 pandemic, including novel COVID vaccines and convalescent plasma (CCP).
Real World Evidence (RWE), as defined by FDA’s Framework for the RWE Program, is the clinical evidence about the usage, potential benefits or risks of a medical product, and is derived from the analysis of RWD. The CBER Biologics Effectiveness and Safety initiative (BEST) was created to allow the exploration of RWD that can be used to identify, validate, and assess exposures to blood, blood components, and vaccines as well as other biologics, and potential adverse events due to those exposures. BEST aims to integrate various RWD sources to generate RWE that may inform the safety and effectiveness evaluations by review teams within the Agency, as well as post-marketing surveillance efforts.
In this session, we will describe types of RWD, its sources, and how FDA assesses its relevance and use in evaluating the safety and effectiveness of medical products. We will elaborate on how CBER is using RWD and RWE to support Benefit-Risk assessments and consider future directions for RWD/RWE that will enhance the authorization, approval and safety surveillance of CBER-regulated products.
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