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Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Epidemiol+Glob+Health 2021 ; 11 (1): 15-19 Nephropedia Template TP
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Pride and Prejudice during the COVID-19 Pandemic: The Misfortune of Inappropriate Clinical Trial Design #MMPMID33009729
Hashmi SK; De Vol E; Hussain F
J Epidemiol Glob Health 2021[Mar]; 11 (1): 15-19 PMID33009729show ga
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 x 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.
|*COVID-19 Drug Treatment[MESH]
|*Information Dissemination/ethics/methods[MESH]
|*Non-Randomized Controlled Trials as Topic/ethics/methods/standards[MESH]
|*Research Design/standards/trends[MESH]
|*Safety Management/ethics/standards[MESH]
|COVID-19/epidemiology[MESH]
|Early Termination of Clinical Trials/methods[MESH]