RESUMEN
This cross-sectional study estimates the trial capacity of sites participating in the COVID-19 convalescent plasma expanded access program.
Asunto(s)
COVID-19 , Humanos , Anticuerpos Antivirales , COVID-19/terapia , Inmunización Pasiva , SARS-CoV-2 , Ensayos Clínicos como Asunto , Sueroterapia para COVID-19RESUMEN
The COVID-19 pandemic has highlighted the challenges of evidence-based health policymaking, as critical precautionary decisions, such as school closures, had to be made urgently on the basis of little evidence. As primary and secondary schools once again close in the face of surging infections, there is an opportunity to rigorously study their reopening. School-aged children appear to be less affected by COVID-19 than adults, yet schools may drive community transmission of the virus. Given the impact of school closures on both education and the economy, schools cannot remain closed indefinitely. But when and how can they be reopened safely? We argue that a cluster randomized trial is a rigorous and ethical way to resolve these uncertainties. We discuss key scientific, ethical, and resource considerations both to inform trial design of school reopenings and to prompt discussion of the merits and feasibility of conducting such a trial.
Asunto(s)
COVID-19/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Proyectos de Investigación , Instituciones Académicas , COVID-19/epidemiología , Análisis por Conglomerados , Control de Enfermedades Transmisibles/métodos , Política de Salud , Humanos , Consentimiento Informado , Pandemias , Salud Pública , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , SARS-CoV-2RESUMEN
Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly.