Toto Neema, Douglas Elaine, Gmeiner Markus, Barrett Lynn K, Lindblad Robert, Makhaza Lumbani, Nedi Wilfred, Phulusa Jacob, Quinnan Gerald V, Sawyer Leigh A, Thole Herbert, Van Voorhis Wesley C, Iroh Tam Pui-Ying
Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Liverpool School of Tropical Medicine, Liverpool, UK.
Trials. 2020 Jul 25;21(1):680. doi: 10.1186/s13063-020-04620-8.
An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resources and experience to conduct International Committee of Harmonisation-Good Clinical Practice (ICH-GCP)-compliant clinical trials.
We present the challenges and lessons learned in implementing a phase 2A, randomized, double-blind, placebo-controlled trial of clofazimine, in treatment of cryptosporidiosis among HIV-infected adults at a single site in Malawi.
Primary challenges are grouped under study initiation, study population, study implementation, and cultural issues. The lessons learned primarily deal with regulatory system and operational barriers, and recommendations can be applied to other human experimental trials in low- and middle-income countries, specifically in sub-Saharan Africa.
This study demonstrated that initiating and implementing human experimental trials in sub-Saharan Africa can be challenging. However, solutions exist and successful execution requires careful planning, ongoing evaluation, responsiveness to new developments, and oversight of all trial operations.
研发一种有效治疗HIV感染者隐孢子虫性腹泻的药物是全球卫生工作的重点。有前景的药物需要在流行地区进行评估，而这些地区可能面临资源匮乏以及缺乏开展符合国际协调会议-良好临床实践（ICH-GCP）标准的临床试验的经验等挑战。
我们介绍了在马拉维的一个单一地点开展一项关于氯法齐明治疗HIV感染成人隐孢子虫病的2A期随机双盲安慰剂对照试验过程中所面临的挑战及吸取的经验教训。
主要挑战分为研究启动、研究人群、研究实施和文化问题几类。吸取的经验教训主要涉及监管系统和操作障碍，相关建议可应用于其他低收入和中等收入国家，特别是撒哈拉以南非洲地区的人体试验。
本研究表明，在撒哈拉以南非洲地区启动和实施人体试验可能具有挑战性。然而，解决办法是存在的，成功执行需要精心规划、持续评估、对新进展做出反应以及对所有试验操作进行监督。
