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                <text>Coronavirus</text>
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                <text>Dominio científico: Coronavirus</text>
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              <text>Pride and Prejudice during the COVID-19 Pandemic: The Misfortune of Inappropriate Clinical Trial Design</text>
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              <text>Shahrukh K. Hashmi, Edward De Vol, Fazal Hussain</text>
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              <text>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.</text>
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              <text>2020</text>
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              <text>covid-19, Clinical trials, multicenter, Primary endpoint, Single-arm</text>
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              <text>10.2991/jegh.k.200729.001</text>
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              <text>Epidemiology and Health</text>
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          <name>Publisher</name>
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              <text>Korean Society of Epidemiology</text>
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              <text>Public aspects of medicine</text>
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