Considerations for Regulatory Oversight of Clinical Trials in the COVID-19 Pandemic, 5 June 2020

Abstract

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 technologies that meet health needs during the COVID-19 pandemic.1 Well-conducted, blinded randomized controlled trials (RCTs) are considered the gold standard of clinical research and constitute the backbone of the procedure for the authorization of new drugs by drug regulatory agencies. CT regulation is focused on protecting the safety, wellbeing and rights of human subjects, ensuring trials are adequately designed to meet sound scientific objectives, and preventing fraud and falsification of data. During the COVID-19 pandemic, there is a moral urgency to conduct CTs that are not only ethically and scientifically rigorous, but that are also done expeditiously. The authorization and control of clinical trials considers ethical and scientific aspects that, according to the governance model defined by each country, assigns roles and responsibilities to various institutions, the most relevant being NRAs, research ethics committees, and, perhaps, other agencies such as the Ministry of Health and/or those with science and technology remits. These institutions must articulate and develop the requirements, guidelines, procedures and forms necessary to align with national, regional, and international guidelines, reflecting the principles enshrined in the Declaration of Helsinki, the International Ethical Guidelines for Health-related Research Involving Humans of the Council of International Organizations of Medical Sciences (CIOMS), The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), those of good clinical practices of the World Health Organization (WHO), and Pan American Health Organization (PAHO) guidance for ethics review and oversight during a pandemic...