Abstract
There is a proliferation of clinical trials worldwide to find effective therapies for patients diagnosed with coronavirus disease 2019 (COVID-19). The endpoints that are currently used to evaluate the efficacy of therapeutic agents against COVID-19 are focused on clinical status at a particular day or on time to a specific change of clinical status. To provide a full picture of the clinical course of a patient and make complete use of available data, we consider the trajectory of clinical status over the entire follow-up period. We also show how to combine the evidence of treatment effects on the occurrences of various clinical events. We compare the proposed and existing endpoints through extensive simulation studies. Finally, we provide guidelines on establishing the benefits of treatments.
Keywords: clinical trials; endpoints; severity rating; statistical power; totality of evidence.
【저자키워드】 clinical trials, Statistical power, endpoints, severity rating, totality of evidence., 【초록키워드】 COVID-19, coronavirus disease, Coronavirus disease 2019, Efficacy, clinical trial, severity, clinical trials, clinical status, Clinical course, Patient, trajectory, therapeutic agent, Statistical power, therapeutic agents, Evidence, endpoints, proliferation, evidence of, Endpoint, follow-up period, available data, effective therapy, treatment effects, simulation studies, Complete, benefit, statistical, Occurrence, diagnosed, events, treatment effect, used to evaluate, 【제목키워드】 Evaluating,