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PSI RWD SIG Webinar: Real-World Evidence Submission - a Case Study in Lung Transplantation

22 March 2022

Presenters: Tae Hyun Jung, U.S. Food and Drug Administration; Tim Weaver, Chronic Disease Research Group; Richard Croy, David Nimke, and Josephine Wolfram, Astellas

The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. In July 2021, tacrolimus was approved for Lung transplantation based solely on RWE and the involved parties share their experience with statisticians in the pharmaceutical community. Three stakeholders – the sponsor, RWD vendor and FDA - share their experiences of the submission and approval process. Topics covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.

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