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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Implementation of good clinical practice guidelines in vaccine trials in developing countries
Vaccine, Volume 25, No. 15, Year 2007
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Description
The practicalities when applying the ICH GCPs (International Conference on Harmonization 1996 Good Clinical Practices [EU, MHLW, FDA. International Conference on Harmonization Guideline for Good Clinical Practice; 1997] in less developed countries (ldcs) are seldom discussed and we found no guidelines as how to "adapt" them. Below we illustrate how ICH GCP principles can be implemented in different settings. We have recently conducted in Asia (Hechi, China; Karachi, Pakistan; Hue, Vietnam; North Jakarta, Indonesia and Kolkata, India) large-scale cluster-randomized effectiveness evaluations of the Vi polysaccharide typhoid fever vaccine (Vi PS project) among approximately 200,000 individuals11The DOMI (disease of the most impoverished) programme is coordinated by the International Vaccine Institute and is funded by the Bill and Melinda Gates Foundation. [Acosta CJ, Galindo CM, Ali M, Abu-Elyazeed R, Ochiai RL Danovaro-Holliday MC et al. A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design. TMIH 2005;10(12):1219-1228]. There is no doubt on the importance of ICH GCP in its contribution to ethical and scientifically sound clinical research. However, when the ICH GCP is implemented in ldcs some considerations must be made in order to adequately tailor them. Vaccine trials in ldcs are a frequent setting for such challenges because of the increased global interest conducting health research in such countries. The ICH GCP principles are discussed below within the framework of this recent typhoid fever vaccine study experience. © 2006 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Acosta, Camilo J.
South Korea, Seoul
International Vaccine Institute, Seoul
Galindo, Claudia M.
South Korea, Seoul
International Vaccine Institute, Seoul
Ochiai, R. Leon
South Korea, Seoul
International Vaccine Institute, Seoul
Danovaro-Holliday, Maria Carolina
South Korea, Seoul
International Vaccine Institute, Seoul
Laure-Page, Anne
South Korea, Seoul
International Vaccine Institute, Seoul
Thiem, Vu
Viet Nam, Hanoi
National Institute of Hygiene and Epidemiology
Jin, Yang
China, Nanning
Guangxi Center for Disease Control and Prevention
Khan, Mohammad Imran
Pakistan, Karachi
The Aga Khan University
Sahito, Shah Muhammad
Pakistan, Karachi
The Aga Khan University
Hamza, Hasan Bin
Pakistan, Karachi
The Aga Khan University
Park, Jinkyung Kyoung
South Korea, Seoul
International Vaccine Institute, Seoul
Lee, Hyejon
South Korea, Seoul
International Vaccine Institute, Seoul
Bock, Hans Ludwig
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Abu-Elyazeed, Remon R.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Egypt, Cairo
Enteric Disease Research Program
Albert, Manuel John
Kuwait, Kuwait City
Kuwait University
Ascaso Terrén, Carlos
Spain, Barcelona
Universitat de Barcelona
Robles, Tonette Q.
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Ali, Mohammad M.
South Korea, Seoul
International Vaccine Institute, Seoul
Ngai, Philip
South Korea, Seoul
International Vaccine Institute, Seoul
Puri, Mahesh K.
South Korea, Seoul
International Vaccine Institute, Seoul
Koo, Young Mo
South Korea, Seoul
International Vaccine Institute, Seoul
Agtini, Magdarina Destri
United States, Bethesda
National Institutes of Health Nih
Soeharno, Rooswanti
United States, Bethesda
National Institutes of Health Nih
Bai-qing, Dong
China, Nanning
Guangxi Center for Disease Control and Prevention
Kohl, Danièle
Belgium, Rixensart
Glaxosmithkline Biologicals S.a.
Xu, Zhiyi
South Korea, Seoul
International Vaccine Institute, Seoul
Ivanoff, Bernard N.
Switzerland, Geneva
Organisation Mondiale de la Santé
Jódar, Luis
South Korea, Seoul
International Vaccine Institute, Seoul
Pang, Tikki Pangestu
Switzerland, Geneva
Organisation Mondiale de la Santé
Bhutta, Zulfiqar A.
Pakistan, Karachi
The Aga Khan University
Clemens, John David
South Korea, Seoul
International Vaccine Institute, Seoul
Statistics
Citations: 31
Authors: 31
Affiliations: 10
Identifiers
Doi:
10.1016/j.vaccine.2006.09.079
ISSN:
0264410X
Research Areas
Infectious Diseases
Study Design
Randomised Control Trial