40 Selecting and Opening a Clinical Research Site in a Low-Resource Setting

Abstract

AbstractConducting clinical research in a public health emergency response not only involves the collective efforts of the scientific community to establish relevant protocols designed to provide answers to the most pressing questions regarding the infectious disease threat, but also requires an infrastructure where research can take place. This chapter identifies factors to consider regarding the who, what, where, when, and how of establishing a clinical research site in a setting where infrastructure may be lacking and few or no clinical trials have been conducted in the past. The chapter also provides a roadmap that describes site selection criteria, checklists for site activation, and considerations for flowcharts to ensure that protocols can be implemented at the site. The chapter concludes with the important reminder that, while every emergency is different from the previous one and lessons learned may not be directly applicable, the experience provides a framework within which to creatively address the next challenge.