title: 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.
authors.affiliation: International Vaccine Institute, Seoul, Republic of Korea. camilo_acosta2003@yahoo.com <camilo_acosta2003@yahoo.com>
authors.forename: Camilo J
authors.initials: CJ
authors.lastname: Acosta
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Galindo
authors.forename: R Leon
authors.initials: RL
authors.lastname: Ochiai
authors.forename: M Carolina
authors.initials: MC
authors.lastname: Danovaro-Holliday
authors.forename: Anne
authors.initials: A
authors.lastname: Laure-Page
authors.forename: Vu Dinh
authors.initials: VD
authors.lastname: Thiem
authors.forename: Yang
authors.initials: Y
authors.lastname: Jin
authors.forename: Mohammad Imran
authors.initials: MI
authors.lastname: Khan
authors.forename: Shah Muhammad
authors.initials: SM
authors.lastname: Sahito
authors.forename: Hasan Bin
authors.initials: HB
authors.lastname: Hamza
authors.forename: Jin Kyoung
authors.initials: JK
authors.lastname: Park
authors.forename: Hyejon
authors.initials: H
authors.lastname: Lee
authors.forename: Hans
authors.initials: H
authors.lastname: Bock
authors.forename: Remon Abu
authors.initials: RA
authors.lastname: Elyazeed
authors.forename: M John
authors.initials: MJ
authors.lastname: Albert
authors.forename: Carlos
authors.initials: C
authors.lastname: Ascaso
authors.forename: Tonette Q
authors.initials: TQ
authors.lastname: Robles
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ali
authors.forename: Philip
authors.initials: P
authors.lastname: Ngai
authors.forename: Mahesh K
authors.initials: MK
authors.lastname: Puri
authors.forename: Young Mo
authors.initials: YM
authors.lastname: Koo
authors.forename: Magdarina D
authors.initials: MD
authors.lastname: Agtini
authors.forename: Rooswanti
authors.initials: R
authors.lastname: Soeharno
authors.forename: Dong
authors.initials: D
authors.lastname: Bai-qing
authors.forename: Danièle
authors.initials: D
authors.lastname: Kohl
authors.forename: Zhi-Yi
authors.initials: ZY
authors.lastname: Xu
authors.forename: Bernard
authors.initials: B
authors.lastname: Ivanoff
authors.forename: Luis
authors.initials: L
authors.lastname: Jodar
authors.forename: Tikki
authors.initials: T
authors.lastname: Pang
authors.forename: Zulfiqar
authors.initials: Z
authors.lastname: Bhutta
authors.forename: John D
authors.initials: JD
authors.lastname: Clemens
mesh_terms: D003906:Developing Countries; D006801:Humans; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods / Q000592:standards*; D014436:Typhoid-Paratyphoid Vaccines / Q000008:administration & dosage; D014611:Vaccination / Q000592:standards*; D014612:Vaccines / Q000008:administration & dosage*
chemical_list: D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; D014612:Vaccines; C057664:Vi polysaccharide vaccine, typhoid