Conducting clinical research in a resource-constrained setting: lessons from a longitudinal cohort study in The Gambia

Abstract

Clinical research conducted to Good Clinical Practice (GCP) standards is increasingly being undertaken in resource-constrained low-income and middle-income countries (LMICs) settings. This presents unique challenges that differ from those faced in high-income country (HIC) contexts, due to a dearth of infrastructure and unique socio-cultural contexts. Field experiences by research teams working in these LMIC contexts are thus critical to advancing knowledge on successful research conduct in these settings. The Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine has operated in The Gambia, a resource-constrained LMIC for over 70 years and has developed numerous research support platforms and systems. The unit was the lead clinical collaborator in a recently completed Expanded Program on Immunization Consortium (EPIC) study, involving a multicountry collaboration across five countries including the USA, Canada, Belgium, Papua New Guinea and The Gambia. The EPIC study recruited and completed follow-up of 720 newborn infants over 2 years. In this paper, we provide in-depth field experience covering challenges faced by the Gambian EPIC team in the conduct of this study. We also detail some reflections on these challenges. Our findings are relevant to the international research community as they highlight practical day-to-day challenges in conducting GCP standard clinical research in resource-constrained LMIC contexts. They also provide insights on how study processes can be adapted early during research planning to mitigate challenges.

Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance

“…The greatest challenge that faced our team was inadequate financial and human capacity. Highly qualified and trained personnel are needed to propose, initiate and implement clinical trials and other types of studies 3 4. Such human resource development requires relatively stable, well-resourced research institutions and well-established science governance systems, which have not been the case in Nigeria and other LMICs 30.…”

“…Clinical trials for identification of efficient and effective new prevention, diagnostic and treatment modalities are also needed to address the disproportionately high burden of communicable (e.g., HIV, tuberculosis and malaria) and non-communicable diseases (e.g., cancer, hypertension and diabetes) in LMICs. However, in many LMICs, especially in sub-Saharan Africa (SSA), there are limited infrastructures to conduct clinical trials and implementation research that drive scientific discovery and answer questions on local and regional health challenges, including multimorbidities such as HIV and cancer 3 4. The process of building research collaborations that develop local research infrastructure is poorly described in the literature.…”

“…These include insufficient funding for research, inadequate infrastructure for research, research-policy misalignment and poor mentorship 3 25–28. Several efforts are being made to improve recruitment and participation in clinical trials around the world 3 4 28 29. While some success has been recorded in building the capacity and infrastructure for research, sustainability remains a challenge 3 4 30.…”

“…Several efforts are being made to improve recruitment and participation in clinical trials around the world 3 4 28 29. While some success has been recorded in building the capacity and infrastructure for research, sustainability remains a challenge 3 4 30. For example, Teklu et al developed a clinical longitudinal cohort of PLWH in Ethiopia to study the impact of ART on women living with HIV (WLWH), but the cohort collapsed after funding ended 28.…”

“…For example, Teklu et al developed a clinical longitudinal cohort of PLWH in Ethiopia to study the impact of ART on women living with HIV (WLWH), but the cohort collapsed after funding ended 28. Imam et al also documented challenges with recruiting sufficient in-country specialists in The Gambia 4. A recent systematic review identified specific challenges with funding and complex regulatory and prolonged administrative processes 3.…”