eBook: The role of RWE in regulatory approvals. Download here.

Friends of Cancer Research: Characterizing the use of external controls for augmenting randomized control arms and confirming benefit

Jeremy Rassen, Sc.D.
Co-founder, President, and Chief Science Officer, Aetion

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Following the Friends of Cancer Research (Friends) 2019 Annual Meeting, Friends published a white paper, “Characterizing the use of external controls for augmenting randomized control arms and confirming benefit.”

Co-authored by Jeremy Rassen, Sc.D., Co-founder, President, and Chief Science Officer of Aetion, the paper is a summary of discussions from a working group that also included the FDA, industry, data providers, academia, and advocacy, and seeks to support the FDA as they explore guidance on the use of RWD to generate external control arms. It offers several approaches to constructing an external control, and provides a case study in relapsed/refractory multiple myeloma.

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