Presented by Dr. Kert Viele of Berry Consultants, LLC.
Few therapies benefit everyone. When we have uncertainty about “who benefits?”, a standard “one size fits all” clinical trial will fail. Enrichment trials prospectively investigate subgroups. During the trial, we estimate the effect of our therapy in each subgroup, and adaptively drop subgroups that are performing poorly, allowing for greater sample sizes in the remaining subgroups. These greater sample sizes allow for increased power in the presence of differential subgroup effects. We will review these methodologies, discuss their benefits and risks (for example, they are typically larger than a standard trial), and provide examples from the literature.
This video has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN268201800008I.
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