Joint reviews and inspections: Strategic forms of collaboration for strengthening the regulatory oversight of vaccine clinical trials in Africa

被引：8

作者：

Maiga, Diadie ^{[1
,2
]}

Akanmori, Bartholomew Dicky ^{[3
]}

Chocarro, Liliana ^{[1
]}

机构：

[1] WHO, Qual Safety & Stand, Dept Immunizat Vaccines & Biol, CH-1211 Geneva, Switzerland

[2] Univ Montreal, Fac Med, Dept Hlth Adm, Montreal, PQ H3C 3J7, Canada

[3] WHO Reg Off Africa, Immunizat & Vaccines Dev Programme, Div Prevent & Control Communicable Dis, Brazzaville, Rep Congo

来源：

VACCINE | 2009年 / 28卷 / 02期

关键词：

Clinical trials regulation; Vaccines; Health systems; Regulatory collaboration; Africa; COMMITTEES; COUNTRIES; MALARIA;

D O I：

10.1016/j.vaccine.2009.09.117

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Vaccine developers are required to submit a clinical trial application to the authorities in each country where a clinical trial will be conducted. The application has to be made both to the relevant Ethics Committees and to the National Regulatory Authorities, and only after appropriate clearance by both can a clinical trial commence. This paper describes two specific strategies, joint reviews of vaccine clinical trial applications and joint inspections of clinical trial sites by groups of countries, as part of a WHO initiative to strengthen capacity for the regulatory oversight of clinical trials in Africa. Significantly, the joint reviews and inspections contributed to reinforcing the capacities of the regulatory authorities as well as defining an efficient process to maximize the quality of the reviews and minimize undue delays. Finally we will suggest complementary mechanisms to overcome the potential limitations of joint reviews and inspections. (C) 2009 Elsevier Ltd. All rights reserved.

引用

页码：571 / 575

页数：5

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