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J Epidemiol Glob Health ; 11(1): 15-19, 2021 03.
Artículo en Inglés | MEDLINE | ID: covidwho-810018

RESUMEN

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.


Asunto(s)
Tratamiento Farmacológico de COVID-19 , Difusión de la Información , Ensayos Clínicos Controlados no Aleatorios como Asunto , Proyectos de Investigación , Administración de la Seguridad , COVID-19/epidemiología , Terminación Anticipada de los Ensayos Clínicos/métodos , Ética , Humanos , Difusión de la Información/ética , Difusión de la Información/métodos , Ensayos Clínicos Controlados no Aleatorios como Asunto/ética , Ensayos Clínicos Controlados no Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados no Aleatorios como Asunto/normas , Proyectos de Investigación/normas , Proyectos de Investigación/tendencias , SARS-CoV-2 , Administración de la Seguridad/ética , Administración de la Seguridad/normas
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