32 Launching a Clinical Research Operation

Résumé fourni par la source

Abstract Launching a research operation to support a clinical trial in the midst of an infectious disease emergency is a daunting task. We know that disease outbreaks and epidemics will occur, but not the time, place, or nature of the disease. There may be many unknowns when the disease first appears. Urgently implemented clinical research can make it possible to mitigate morbidity and mortality, help control or end disease transmission, and improve response to subsequent outbreaks. If, as is likely, an outbreak with pandemic potential occurs in a country with little research capacity and meager healthcare infrastructure, the research response will be more difficult but no less urgent. Such countries, especially outside major cities, often lack dependable communications, electrical power, clean water, and transportation. This chapter and other chapters in the section of the book describe some of the obstacles involved and how to overcome them, based on the personal experience as well as the professional expertise of the authors. This chapter lays out a number of organizational requirements for setting up a research program, including the various specialized teams needed. Authors who have worked in such specialized teams provide their perspectives on the requirements in each of these specialized areas in the following chapters.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.