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Lessons from the field: the conduct of randomized controlled trials in Botswana

机译：实地经验：博茨瓦纳的随机对照试验

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The conduct of randomized controlled trials (RCTs) in low-resource settings may present unique financial, logistic, and process-related challenges. Middle-income countries that have comparable disease burdens to low-income countries, but greater availability of resources, may be conducive settings for RCTs. Indeed, the country of Botswana is experiencing a rapid increase in the conduct of RCTs. Our objective was to explore the experiences of individuals conducting RCTs in Botswana to gain an understanding of the challenges and adaptive strategies to their work. We conducted in-depth interviews with 14 national and international individuals working on RCTs in Botswana. Participants included principal investigators, research coordinators, lab technicians, research assistants, and other healthcare professionals. Interviews were audiotaped, transcribed verbatim, and coded for thematic analysis. Five primary themes were identified: ethics board relationships (including delays in the process); research staff management (including staff attrition and career development); study recruitment and retention (including the use of reimbursements); resource availability (including challenges accessing laboratory equipment); and capacity-building (including issues of exporting locally sourced samples). These themes were explored to discuss key challenges and adaptive strategies. This study offers a first-hand account of individuals engaged in conducting RCTs in Botswana, a nation that is experiencing a rapid increase in research activities. Findings provide a foundational understanding for researchers in Botswana and trial managers in similar settings when planning RCTs so that the conduct of research does not outpace the ability to manage, support, and regulate it.
机译：在资源匮乏的环境中进行随机对照试验（RCT）可能会带来独特的财务，物流和过程相关挑战。与低收入国家相比，疾病负担可比的中等收入国家，但资源更多，可能是RCT的有利环境。确实，博茨瓦纳国家的RCT行为正在迅速增加。我们的目标是探索在博茨瓦纳开展RCT的个人的经验，以了解其工作面临的挑战和适应性策略。我们对在博茨瓦纳从事RCT的14个国家和国际个人进行了深入采访。参加人员包括主要研究人员，研究协调员，实验室技术人员，研究助理和其他医疗保健专业人员。对访谈进行录音，逐字记录并进行主题分析编码。确定了五个主要主题：道德委员会关系（包括流程延迟）;研究人员管理（包括人员流失和职业发展）;研究招募和保留（包括报销的使用）;资源可用性（包括获取实验室设备的挑战）;和能力建设（包括出口本地采购样品的问题）。探索了这些主题以讨论关键挑战和适应策略。这项研究提供了在博茨瓦纳从事研究活动的个人的第一手资料，该国正在经历研究活动的迅速增加。研究结果为博茨瓦纳的研究人员和类似环境中的试验管理人员在规划随机对照试验时提供了基础理解，因此研究的进行不会超过管理，支持和规范试验的能力。

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