33.2 In Practice: Independent Monitoring of Emergency Response Clinical Trials

Abstract

AbstractIndependent monitoring of clinical trial studies safeguards the rights, safety, and welfare of patients who have agreed to participate in clinical trials of experimental medical countermeasures. Monitoring is especially important and may be more difficult to implement, in countries with limited medical care and medical research infrastructure and personnel, a shortfall often exacerbated by poverty, poor transport and communications, and uncertain security. The randomized controlled trial of Ebola virus disease therapeutics implemented in the northeastern Democratic Republic of the Congo (DRC) during the 2018–2020 Ebola outbreak there demonstrates that it is possible to monitor the adequacy of trial sites and resources, qualifications and proper training of investigators, protocol implementation, and study task assignments even during an emerging outbreak in an insecure environment. Independent monitoring buttresses continuous quality improvement by and for all research stakeholders. It requires flexibility and efficient communications and can help build local capacity for research when that is a goal of the program.