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

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Ongoing clinical trials during COVID-19 can be differentially impacted, and therefore, mitigations of the impacts must be proportional to the degree of the impacts. For clinical trials just started with little data collected, the sponsor may wish to put the trial on hold and redesign the trial since COVID-19 has impacted the workforce and health care system in so many different ways, including the emergence of new digital technology and telemedicine. For ongoing clinical trials with substantial data collection, we consider the following classification. An ongoing trial is minimally affected if the trial is near completion, or both treatment and data collection are minimally affected. An ongoing trial is moderately affected if modification of the trial design can be made so that the trial can continue. An ongoing trial is severely affected if the trial has to be put on hold.