Abstract
Conducting clinical trials to prevent and treat infectious diseases in pregnancy is essential to saving maternal and newborn lives, though it is fraught with challenges. We have been conducting research in malaria treatment and prevention in children and pregnant women in Blantyre, Malawi for over a decade. Here, we review some of the unique challenges that we have faced in leading research studies that with rigor and integrity and maintaining the highest ethical standard. We conclude with concrete strategies to overcome some of the apparent obstacles that frequently focus on building trust through bidirectional communication with local health workers and communities. We also highlight the key role of local and international investigators to advocate for the health of the communities in which they work.
Highlights
Most clinical researchers would have had the experience of a disease sharply decreasing in prevalence, or even virtually disappearing, while the disease is under study
It contributes to the failure to conduct adequately powered studies to detect differences between treatment and control groups because the overall rate of either the disease or adverse outcome of interest decreases significantly due to the conditions of the clinical trial
Our review focuses on unique challenges of clinical trials in resource limited settings using illustrative examples; our research group has encountered conducting studies to evaluate strategies to prevent and treat malaria among pregnant women in Malawi
Summary
Most clinical researchers would have had the experience of a disease sharply decreasing in prevalence, or even virtually disappearing, while the disease is under study. The conditions of a clinical trial often alter the natural history of diseases and the prevalence of adverse outcomes. These complicating factors limit the ability to conduct ethical studies that provide generalizable information, especially in resource-limited settings, where the reality of access to health care and disease prevention is often much less than the stated standard of care [1]. Our review focuses on unique challenges of clinical trials in resource limited settings using illustrative examples; our research group has encountered conducting studies to evaluate strategies to prevent and treat malaria among pregnant women in Malawi. This discussion is not intended to be exhaustive but rather a framework in which to consider and trouble-shoot the unique obstacles
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