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Webinar: Biostatistics and Bioinformatics Seminar – “From Real-World Data (RWD) to Real-World Evidence (RWE)”
February 11, 12:00 pm to 1:00 pm
“From Real-World Data (RWD) to Real-World Evidence (RWE)” will be presented by Yixin Fang, PhD, Director of GMA-Statistics, AbbVie Inc.
As defined in the Framework for FDA’s RWE Program released in December 2018, Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care that are routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product that is derived from analysis of RWD. The big question is: How do we derive RWE from analysis of RWD? Bearing this question in mind, in this presentation, Dr. Fang will discuss three key steps in the RWD/RWE research:
- defining an estimand that translates the research objective into a precise definition of the treatment effect that is to be estimated;
- constructing an efficient estimator (minimum-variance unbiased estimator) for the estimation of the estimand; and
- conducting sensitivity analysis to explore the robustness of the inference to deviations from the underlying assumptions.
FDA is working on guidelines to harmonize RWD applications and monitor the safety and effectiveness of pharmaceutical drugs using RWE. The organization hopes the discussion of these three steps is helpful for clinicians and statisticians who are eager to embark on their journeys of the RWD/RWE research.
Participants may also join by calling 929-205-6099, meeting ID 322 043 373. If prompted, enter passcode 167660.