Statistical Considerations for Clinical Trials During COVID-19: A Two-Stage Adaptive Design for Clinical Trials with Chronic Conditions

For COVID-19 affected ongoing clinical trials in patients with chronic diseases, a practical and immediate mitigation action is to pause the clinical trial and restart it after COVID-19. Patients already enrolled the trial are terminated from the study, following the standard study termination procedure of the original trial design, which includes collecting 30 days safety data and in addition COVID-19 related information such as immunodeficiency, COVID-19 exposure or infection, etc. New patients will be enrolled post COVID-19 following a modified study design. This strategy has several advantages: first and foremost, it provides maximum protection of patients, and secondly it alleviates burdens of healthcare workforce and clinical sites and allows resources to focus on treating COVID-19 patients, and thirdly, it gives sponsors ample time to assess how changes in healthcare workforce and clinical site operations would affect the clinical trial and develop appropriate trial modifications.