36 Safety and Pharmacovigilance in Emergency Research Response

Pharmacovigilance is an essential element of clinical trials. Even though a trial is based on the hypothesis that the intervention being tested will provide benefits that outweigh the risks, that hypothesis often turns out to be wrong. The impact of the COVID-19 pandemic and coverage in traditional and social media have raised public awareness of the clinical research enterprise, and in particular the pharmacovigilance (PV) and safety aspects of emerging and re-emerging infectious disease (EID) research response. Fundamental concepts of PV and clinical research, safety goals, and methods are introduced and explained, and the key players, factors, constraints, and stakeholders comprising the system are covered, with examples drawn from the response to both the COVID-19 pandemic and the 2018 Democratic Republic of the Congo (DRC) Ebola outbreak. Finally, key operational concepts, preparedness activities, and global response considerations are presented to help practitioners assess their personal, programmatic, and jurisdictional readiness to successfully develop and adapt research pharmacovigilance and safety programs in the context of EID response.