Abstract
BackgroundThe 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.MethodsWe 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.ResultsFive 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.ConclusionsThis 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.
Highlights
The conduct of randomized controlled trials (RCTs) in low-resource settings may present unique financial, logistic, and process-related challenges
Unique to the RCT design is the random assignment of participants to a treatment or intervention group, which reduces the potential for systematic biases that may compromise internal validity in observational epidemiologic studies [2]
RCTs have been critical to advancing public health and clinical research; many important medical treatments such as the wellknown HIV drug, Tenofovir, have only been approved for population-wide use after a long series of RCTs [3]
Summary
The conduct of randomized controlled trials (RCTs) in low-resource settings may present unique financial, logistic, and process-related challenges. The randomized controlled trial (RCT) is critical to exploring the impact of interventions and is the ideal study design to establish causality [1]. In Peru, researchers found that community members were hesitant to sign study consent forms due to cultural resistance to foreign documents as a result of past instances of land being unjustly seized by foreigners [5]. These few examples tell a greater narrative of cultural and linguistic challenges associated with the conduct of research in global settings.
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