On Friday September 11, Cyrus Mehta, co-founder of Cytel, will be delivering a talk to the Heart Failure Collaboratory, on how adaptive designs can be utilized to salvage trials disrupted by COVID-19. The Heart Failure Collaboratory is a public-private consortium with FDA, and will be hosting a day long symposium online, on the application of innovative methods for drug and device studies in the age of COVID-19.
FDA will be represented by members of the Center for Drug Evaluation and Research (CDER) and the Center for Device and Radiological Health (CDRH). Attendant panelists include a distinguished range of physicians and statisticians, including former CDER head Ellis Unger, as well as longtime Cytel friend and eminent biostatistician Professor LJ Wei.
The challenges faced by heart failure trials in the coronavirus era include the familiar challenges of missing patient visits, slower enrollment, loss of power, and so forth. Adaptive designs can be useful when this occurs. For example, sample size re-estimations have become critical for trial re-designs, while decisions about early stopping and other aspects of trial flexibility are becoming far more prevalent and require sound statistical judgment.
The Heart Failure Collaboratory will also consider the importance of Bayesian designs to handle missing data or small samples, and will consider issues that arise involving implementation of both adaptive and Bayesian methods.
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