Implementation of good clinical practice guidelines in vaccine trials in developing countries.
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.
Acosta
Camilo J
CJ
International Vaccine Institute, Seoul, Republic of Korea. camilo_acosta2003@yahoo.com <camilo_acosta2003@yahoo.com>
Galindo
Claudia M
CM
Ochiai
R Leon
RL
Danovaro-Holliday
M Carolina
MC
Laure-Page
Anne
A
Thiem
Vu Dinh
VD
Jin
Yang
Y
Khan
Mohammad Imran
MI
Sahito
Shah Muhammad
SM
Hamza
Hasan Bin
HB
Park
Jin Kyoung
JK
Lee
Hyejon
H
Bock
Hans
H
Elyazeed
Remon Abu
RA
Albert
M John
MJ
Ascaso
Carlos
C
Robles
Tonette Q
TQ
Ali
Mohammad
M
Ngai
Philip
P
Puri
Mahesh K
MK
Koo
Young Mo
YM
Agtini
Magdarina D
MD
Soeharno
Rooswanti
R
Bai-qing
Dong
D
Kohl
Danièle
D
Xu
Zhi-Yi
ZY
Ivanoff
Bernard
B
Jodar
Luis
L
Pang
Tikki
T
Bhutta
Zulfiqar
Z
Clemens
John D
JD
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*
D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; D014612:Vaccines; C057664:Vi polysaccharide vaccine, typhoid