Jumping over Clinical Research Hurdles Abroad: Strategies for Overcoming Challenges

Wednesday, October 10, 2012 — Poster Session II
Noon – 2:00 p.m	Natcher Conference Center, Building 45	NIAID	CLIN/TRANS-5

Authors

• J.N. Beeler
• L.M. Harmon
• K.M. Watkins
• J. Pierson
• S.E. Vogel
• B. Baseler
• S.M. Simpson

Abstract

Clinical Research Directorate/CMRP, SAIC-Frederick, Inc., Frederick National Laboratory for Clinical Research, Frederick, MD 21702 ABSTRACT When implementing and conducting clinical studies, investigators face a myriad of challenges and obstacles that are compounded when these studies occur internationally. Logistical challenges include: additional required approvals (local IRB/EC, government bodies/Ministries of Health, and other entities); interactions with in-country entities (e.g. Contract Research Organizations/ Site Management Organizations); limitations in clinical, laboratory, and technical capabilities: importation issues (study agents and supplies); and storage and shipment of collected specimens. In addition, cultural and ethical barriers to international research include language differences, illiteracy/low literacy rates, cultural norms, and limited or nonexistent access to healthcare of many populations in which international studies are conducted. The combination of experience, lessons learned, development of tools and metrics aids researchers in generating effective strategies for meeting challenges and overcoming such obstacles. This poster aims to represent a concise compilation of many of the issues clinical research teams face when implementing and conducting international clinical research studies, and to provide metrics and experience-based suggestions for resolving these issues. Funded by NCI Contract No. HHSN261200800001E. This research was supported [in part] by the National Institute of Allergy and Infectious Diseases.

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