Abstract:
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The U.S. Food and Drug Administration (FDA) has issued guidance delineating general considerations for conducting clinical trials of investigational drugs during the COVID-19 pandemic. FDA recommends that sponsors should consider how to analyze data from participants who are missing endpoint ascertainment or for whom the investigational product was interrupted because of SARS-CoV-2 infection. Since the pandemic's beginning, it has been globally observed that competing risks, such as death due to COVID-19, can occur before the event of interest in randomized clinical trials where the primary endpoint of a trial is survival time. Consequently, the statistical power over the originally planned sample size warrants careful re-assessment to overcome the loss of information from the impact of COVID-19. In this study, we have performed simulations to assess the extent of the impact of COVID-19 on the statistical power and number needed to treat (NNT) in survival trials in the context of competing risks. We provide practical statistical considerations for planning a trial to ensure appropriate statistical power and NNT to detect the clinical efficacy of investigational drugs in clinical t
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