Implementation of good clinical practice guidelines in vaccine trials in developing countries

Camilo J. Acosta, Claudia M. Galindo, R. Leon Ochiai, M. Carolina Danovaro-Holliday, Anne Laure-Page, Vu Dinh Thiem, Yang Jin, Mohammad Imran Khan, Shah Muhammad Sahito, Hasan Bin Hamza, Jin Kyoung Park, Hyejon Lee, Hans Bock, Remon Abu Elyazeed, M. John Albert, Carlos Ascaso, Tonette Q. Robles, Mohammad Ali, Philip Ngai, Mahesh K. PuriYoung Mo Koo, Magdarina D. Agtini, Rooswanti Soeharno, Dong Bai-qing, Danièle Kohl, Zhi Yi Xu, Bernard Ivanoff, Luis Jodar, Tikki Pang, Zulfiqar Bhutta, John D. Clemens

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2852-2857
Number of pages6
JournalVaccine
Volume25
Issue number15
DOIs
StatePublished - Apr 12 2007

Keywords

  • Cluster randomized trials
  • GCP
  • Good clinical practice guidelines
  • ICH-GCP
  • Vaccine trials: Developing countries

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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