Emergency Use of Unproven Interventions Outside of Research. Ethics Guidance for the COVID-19 Pandemic, 25 June 2020
Gov't Doc #
MetadataShow full item record
Other Language Versions
The COVID-19 pandemic presents us with the moral urgency to conduct rigorous research as soon as possible to produce evidence about the safety and efficacy of interventions to treat or prevent COVID-19. However, as in previous emergencies, marked by high mortality and the absence of safe and efficacious treatments, interventions that have not been previously proven for COVID-19 are being offered outside of protocols of research with human subjects. Since the safety and efficacy of these interventions have not been proven yet, their risk-benefit profile is unknown. Yet in the exceptional circumstances of the pandemic, they are being offered as an attempt to advance access to interventions that may benefit patients. As recommended by the Pan American Health Organization and the World Health Organization, unproven interventions should be offered within research protocols, and specifically within randomized controlled trials capable of assessing safety and efficacy.
This notice should be preserved along with the article's original URL.Attribution-NonCommercial-ShareAlike 3.0 IGO
Showing items related by title, author, creator and subject.
The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges Carracedo, Sarah; Palmero, Ana; Neil, Marcie; Hasan-Granier, Anisa; Saenz, Carla; Reveiz, Ludovic (2020-12-21)[ABSTRACT]. A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region ...
El panorama de los ensayos clínicos sobre COVID-19 en América Latina y el Caribe: evaluación y desafíos Carracedo, Sarah; Palmero, Ana; Neil, Marcie; Hasan-Granier, Anisa; Saenz, Carla; Reveiz, Ludovic (2021-03-04)[RESUMEN]. Se está llevando a cabo un número considerable de ensayos clínicos en todo el mundo en respuesta a la pandemia de COVID-19, incluso en países de ingresos bajos y medios como los de América Latina y el Caribe. ...
Pan American Health Organization; Health Systems and Services (HSS) (Washington, D.C., PAHO, 2020-06-05)This document provides national regulatory authorities (NRAs) with guidance for the regulation of clinical trials (CTs) in order to promote the investigation and use of safe and efficacious medicines and other health ...