The FDA uses Real Word Data (RWD) to evaluate biologics. RWD is data relating to patient health status/health care delivery. It may be found in Electronic Health Records (EHRs), claims, registries, etc. RWD-informed benefit-risk assessments (B-RA) have been used for evaluating interventions for SARS-CoV-2, including COVID vaccines and convalescent plasma (CCP). Real World Evidence (RWE) is clinical evidence about the usage and potential benefits/risks of a product and is derived from the analysis of RWD. CBER Biologics Effectiveness and Safety Initiative (BEST) explores RWD to identify and assess exposures to blood, biotherapies, and vaccines and subsequent potential adverse events. We describe types of RWD and how the FDA assesses its relevance/use in evaluating safety and effectiveness. We will show how CBER is using RWD/RWE to support B-RA and consider future directions to enhance the authorization, approval, and safety of CBER-regulated products.
Describe Real World Data (RWD) and its use in FDA post-market safety surveillance. Recognize the important new developments in data integration relevant to RWD and electronic health record (EHR) use for regulatory purposes.
Identify the tools and resources FDA uses to monitor current exposures to biologics, to mine outcomes, and explain how they can be applied to improve public health.
Discuss the FDA Benefit-Risk framework for new drug and biological products and how RWD can inform parameters for these risk assessments.