Statistical Considerations for Clinical Trials During COVID-19: Integrated Analysis of Efficacy (IAE) with Adaptive Estimands

In this article, we apply this framework for moderately affected ongoing clinical trials with an integrated analysis of efficacy (IAE) approach to address unplanned protocol deviations affected by COVID-19, while still maintaining the integrity of statistical inference and interpretability of study results. It is assumed that the trial has finished patient accrual and the sample size of the original design is conservative enough that no new patients are needed.