Statistical Considerations for Clinical Trials During COVID-19: Interim Analysis with Adaptive Estimands Based
COVID-19 affects ongoing clinical trials in many different ways, which in turn affects many aspects of statistical inference. To comprehensively describe and capture the multitudes of COVID-19 impacts, Liu and Peace (2020a) describe ongoing clinical trials with substantial data collection as minimally affected, moderately affected and substantially affected. Moderately affected ongoing trials are further classified according to whether an interim analysis is present during COVID-19, both are covered by an adaptive estimand framework based on blinded data review. We apply this framework for moderately affected ongoing clinical trials where blinded data review results in a decision to add a formal interim analysis, or to modify an original planned interim analysis.
Liu, Qing, Karl E. Peace.
"Statistical Considerations for Clinical Trials During COVID-19: Interim Analysis with Adaptive Estimands Based."