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This presentation will discuss the integrated nature of epidemiology and statistics in the design and conduct of studies using RWD along the evidence generation continuum, with a focus on regulatory objectives. By highlighting oncology specific examples as well as recent draft RWE guidances, the presentation seeks to review the current progress and potential possibilities for the application of RWD in the context of medical product safety and effectiveness evaluation.
Donna Rivera is the associate director for pharmacoepidemiology at the US Food and Drug Administration Oncology Center of Excellence. She leads the Oncology Real-World Evidence Program, focusing on the use of real-world data and real-world evidence for regulatory purposes, as well as managing the real-world data research portfolio strategy and development of regulatory policy. Rivera has extensive research experience in the use of real-world data to advance health equity, observational study designs and methodological approaches, and appropriate uses of real-world data for medical development to increase access of effective therapies to patients. She is currently a Scientific Executive Committee member for the COVID-19 and Cancer Consortium and leads Project Post COVIDity, a collaborative real-world data effort to assess longitudinal sequalae of COVID-19 on patients post infection.