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Challenges for Clinical Research in Diverse Global Settings

Thursday, September 15, 2016 — Poster Session II

12:00 p.m. – 1:30 p.m.
FAES Terrace
NIAID
RSCHSUPP-12

Author

  • S Weiss

Abstract

This poster will illustrate and synthesize various steps in the development and implementation of clinical research programs and on-the-ground infrastructure for a cross section of infectious disease drug trials in a portfolio consisting of approximately 57 protocols at 77 sites in 49 cities in 18 different countries. From a systems theory perspective, we conducted a cross-sectional analysis and compiled data on the incremental steps and complex components required to launch and run drug trials in diverse global settings, following the research from inception, to engagement, to outcome, including delivery of on-the-ground infrastructure and services needed to run the drug trials. We identified several complex contextual and intervening variables, such as geographical, political, societal and cultural factors, as well as laws governing clinical research and subject protection, that impacted the research environment and process across all sites. We also identified specific exigencies in locations experiencing rampant infectious disease emergencies. It is critically important to understand on-the-ground challenges faced in conducting clinical research in resource-poor environments that are stricken with a rapidly spreading infectious disease. Practical approaches are required to engage governmental as well as local decision leaders in order to rapidly enlist cooperation, establish testing facilities, and enroll subjects in clinical research. Efficient methods for human subject review, patient recruitment and consent, collection and testing of samples, and delivery of prophylactic or therapeutic agents to study subjects requires adaptation to a host of local environmental and social exigencies.

Category: Research Support Services