Statistical Considerations for Clinical Trials During COVID-19: Blinded Data Review for Adaptive Estimands (Part III)

Document Type

Article

Publication Date

4-15-2020

Publication Title

LinkedIn

Abstract

As stated early in part I of the article, the focus of this article is for moderately COVID-19 affected ongoing trials where no formal interim analysis is planned. This requires a comprehensive assessment of each attribute of an estimand affected by unplanned trial modifications due to COVID-19. In addition, a formal process for adaptive statistical analysis planning, as described by Liu and Chi (2010a) and restated below, is also required.

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