Identifying and assessing the capacity and experience of trial sites in low- and middle-income countries for high-quality randomised drug trials in maternal and perinatal health

Abstract

Existing international consortia for drug trials in maternal and perinatal health have focused largely on pragmatic trials using off-label medicines. This study aimed to identify and assess the capacity and experience of sites in low- and middle-income countries (LMICs) for conducting trials for regulatory approval of medicines for pregnancy-related conditions. We systematically reviewed site assessment checklists across any disease area to develop a maternal trial site assessment checklist. The checklist was pretested, revised and used to collect data from trial sites in LMICs. Sites were systematically identified from a scoping review of maternal trials conducted in LMICs, known networks and snowball searching. Data reported by sites were verified against publicly accessible sources (clinical trial registries and published articles). We contacted 106 sites in 30 countries, of which 49 (46.2%) sites in 21 countries completed the checklist. Sites were from five regions-Sub-Saharan Africa (37), South Asia (6), Latin America and the Caribbean (4), Middle East and North Africa (1) and East Asia and the Pacific (1). More than 70% of responding sites had the requisite physical infrastructure, clinical and research staff, ethics, participant recruitment and data management services to conduct randomised trials. Respondents collectively identified 52 completed, ongoing or planned maternal trials across their sites. Of these 52 trials, 16 (30.8%) were Good Clinical Practice-compliant, 22 (42.3%) were phase III and one was a regulatory trial. 14 trials were conducted by a collaborative group established mostly for a specific trial or a small group of related trials. Only two of these groups were pre-established trial networks. While there is some capacity to conduct high-quality maternal drug trials in LMICs, effective research collaborations are needed to further strengthen and expand this capacity. Establishing a sustainable LMIC-based trial network will accelerate the development and testing of novel drugs to improve maternal and newborn health outcomes in these regions.

Keywords: Epidemiology; Global Health; Health services research; Obstetrics; Public Health.

Figure 1. Number of study sites per country.

Figure 2. Phase of completed, ongoing and planned maternal and perinatal health trials (n=52 trials). NR/NA, not reported or not applicable (ie, for interventions other than drugs and vaccines).