Real-World Data Can Include EUA Observations, US FDA Final Guidance Says
Executive Summary
Agency clarifies expectations for non-interventional studies providing RWD to support regulatory decisions while continuing to emphasize familiar themes around early interaction and stringent data practices.
You may also be interested in...
FDA Postmarket Guidance Hammers Home Positions On Foreign Trials, Real-World Evidence
US agency emphasizes and formalizes long-standing viewpoints on hot topics including accelerated approval in a new guidance on postmarket study diversity.
External Controls: FDA Guidance Provides Clarity But Does Little To Remove Hurdles
Agency discourages use of externally controlled trials in all but a very limited number of situations truly ripe for such an approach; new draft guidance discusses at length the various confounding factors that can introduce bias into a comparison between an investigational treatment and an external control using either real-world data or data from another clinical trial.
Real-World Evidence: CDC Prioritizing Populations, Outcomes For COVID-19 Vaccine Effectiveness Studies
Strategy for assessing how the earliest vaccines to reach market perform beyond clinical trials includes leveraging existing surveillance and data platforms, and employing a diversity of study approaches, CDC epidemiologist says; high-priority areas for study include protection against symptomatic illness among health care workers and prevention of severe disease in the elderly.