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

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 individuals(1)[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.

journal_name

Vaccine

journal_title

Vaccine

authors

Acosta CJ,Galindo CM,Ochiai RL,Danovaro-Holliday MC,Laure-Page A,Thiem VD,Jin Y,Khan MI,Sahito SM,Hamza HB,Park JK,Lee H,Bock H,Elyazeed RA,Albert MJ,Ascaso C,Robles TQ,Ali M,Ngai P,Puri MK,Koo YM,Agtini MD,So

doi

10.1016/j.vaccine.2006.09.079

subject

Has Abstract

pub_date

2007-04-12 00:00:00

pages

2852-7

issue

15

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(06)01081-4

journal_volume

25

pub_type

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