Abstract
This paper describes the need to prepare for the development of antiviral therapeutics for the next pandemic. Preparation would consist of a stockpiling of best practices for clinical trial design, analysis and operations during the current SARS-CoV-2 pandemic as well as continuous development of treatments and methodology between pandemics. This development would be facilitated by a global clinical trial pandemic reserve similar to the military reserves consisting of medical and quantitative methods professionals who would remain engaged between pandemics. Continuous identification of potential antiviral drugs and diagnostic methods would also be needed. Specific methodology addressed includes the importance of large simple trials, follow up time, efficacy endpoint, appropriate estimands, non-inferiority trials, more sophisticated patient accrual models and procedures for data sharing between clinical trials.
Keywords: COVID-19; Centralized statistical monitoring; Drug development; Estimands; Large simple trials.
【저자키워드】 COVID-19, Drug development, Centralized statistical monitoring, Estimands, Large simple trials., 【초록키워드】 Treatment, Efficacy, clinical trial, pandemic, Drug development, SARS-CoV-2 pandemic, antiviral drugs, clinical trials, drug, antiviral drug, Clinical trial design, non-inferiority, Patient, Pandemics, antiviral therapeutics, methodology, diagnostic methods, Quantitative, trials, Diagnostic method, Analysis, best, Endpoint, preparation, professional, Specific, statistical, include, facilitated, addressed, Continuous, 【제목키워드】 pandemic, Trial, clinical,