Abstract
Coronavirus Disease 2019 (COVID-19) is a rapidly evolving global pandemic for which more than a thousand clinical trials have been registered to secure therapeutic effectiveness, expeditiously. Most of these are single-center non-randomized studies rather than multi-center, randomized controlled trials. Single-arm trials have several limitations and may be conducted when spontaneous improvement is not anticipated, small placebo effect exists, and randomization to a placebo is not ethical. In an emergency where saving lives takes precedence, it is ethical to conduct trials with any scientifically proven design, however, safety must not be compromised. A phase II or III trial can be conducted directly in a pandemic with appropriate checkpoints and stopping rules. COVID-19 has two management paradigms- antivirals, or treatment of its complications. Simultaneous assessment of two different treatments can be done using 2 × 2 factorial schema. World Health Organization’s SOLIDARITY trial is a classic example of the global research protocol which can evaluate the preferred treatment to combat COVID-19 pandemic. Short of that, a trial design must incorporate the practicality of the intervention used, and an appropriate primary endpoint which should ideally be a clinical outcome. Collaboration between institutions is needed more than ever to successfully execute and accrue in randomized trials.
Keywords: COVID-19; Clinical trials; multi-center; primary endpoint; single-arm.
【저자키워드】 COVID-19, multi-center, clinical trials, primary endpoint, single-arm., 【초록키워드】 Treatment, coronavirus disease, Coronavirus disease 2019, clinical trial, pandemic, Randomized controlled trials, Trial, randomization, antivirals, COVID-19 pandemic, Intervention, Clinical outcome, global pandemic, controlled trials, clinical, management, therapeutic, Effectiveness, complications, Placebo, collaboration, primary endpoint, Placebo effect, Emergency, classic, Health Organization, World Health Organization, randomized trials, Simultaneous, Research protocol, Registered, single-center, several limitations, MOST, non-randomized studies, precedence, practicality, single-arm, evaluate, example, conducted, anticipated, non-randomized study, secure, several limitation, 【제목키워드】 clinical, Pride and Prejudice,