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Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study

机译：在撒哈拉以南非洲进行临床试验：从马拉维隐孢子虫研究中吸取的挑战和经验教训

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BACKGROUND: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.METHODS: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.RESULTS: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.CONCLUSION: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.
机译：背景：治疗艾滋病毒感染的个体中的腹泻腹泻的有效药物是全球性的健康优先事项。有希望的药物需要在流行区域中评估可能因缺乏资源和经验而受到挑战，以进行国际协调委员会 - 良好的临床实践（ICH-GCP） - 综合临床试验。方法：我们展示了挑战和经验教训在马拉维的单一站点中实施氯氟氮杂志的氯噻嘧啶的氯氟沙亚胺的氯氟氮随机孢子酰亚胺的肝孢子酰亚胺神经刺激症的治疗中的第2A期。结果：在研究启动，研究人口，研究实施中分组主要挑战，和文化问题。这些经验教训主要涉及监管制度和业务障碍，建议可以应用于低收入和中等收入国家的其他人类实验试验，特别是在撒哈拉以南非洲。结论：本研究表明，启动和实施人类的实验试验在撒哈拉以南非洲可能挑战。但是，解决方案存在和成功执行需要仔细规划，持续评估，对新发展的响应，以及对所有试验的监督。

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