Assessment of capacity for conducting drug trials in Ethiopia: a cross-sectional situation analysis

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Addis Abeba University


Abstract Background: Several development organizations have argued that clinical trials (CTs) in LMICs are crucial for advancing public health and development. In order to ensure that clinical trials facilities (CTFs) can respond to this demand, it is vital that a country has sufficient capacity in various aspects including infrastructure to conduct CTs. Despite, different capacity challenges that affecting research systems in LMICs have been recognized; substantial amount of this evidence is inferred from experiences with specific institutions or programmes and does not build on systematic baseline data and conceptual frameworks. Furthermore, CTs funders are increasingly looking for evidence that investigators are linked to CTFs with sufficient expertise and infrastructure, so it is critical that the prevailing capacity of this resource is assessed and the need for any further capacity strengthening is identified. Objective: To assess existing capacity of conducting clinical trials, perceived gaps and priorities for capacity strengthening for CTFs in Ethiopia. Methods: An institutional-based cross-sectional situational analysis was carried out using mixed methods approaches: online semi-structured interviews with key informants, document review, and an email-based, self-administered checklist of key domains of CTs infrastructure and capacity. The data was collected from September-November 2020. Descriptive statistical methods were used to summarize quantitative data. Qualitative data were transcribed verbatim and analyzed using a framework approach. NVivo software version 12 (QSR International Pty Ltd.) was used to manage qualitative data Findings from quantitative and qualitative study components were triangulated. Results: Of the 27 CTFs currently conducting drug trials in Ethiopia, 13 (48% response rate) responded to at least one assessment, 7 responded to both assessments, 3 responded only to the quantitative questionnaire and 3 responded only to qualitative interview. The results from the 10 CTFs who responded to the quantitative assessment indicated that they had 159 staff linked to the CTF, comprising 112 (70.4%) of the scientific staff and 47 (29.6%) support staff. Among the 10 leading causes of death in Ethiopia, only two were included in the trial portfolio of the CTFs. A total of 35 CTs had been conducted in the 10 CTFs, with 46% of these being locally developed protocols and phase III trials. Two CTFs reported ownership of research laboratory and data management units with external certification. Onsite monitoring was used by most CTFs, but the indicators that were monitored varied across the CTFs. Synthesis of nine key informant interviews highlighted the current capacity challenges, identified priority areas to develop capacity and the factors affecting availability of CTF funds and the sustainability of CTFs infrastructure. Conclusions: This study has identified that Ethiopian CTFs have limited capacity to conduct CTs due to a lack of physical infrastructure, workforce, CTs experiences, and data management, as well as a lack of institutional structures to support CTs at various levels. Furthermore, a number of priority areas for capacity development have been identified, calling for a coordinated effort of different stakeholders and funders.



Capacity, Capacity Assessment, Clinical trials, Good Clinical Practice, Clinical trials facility.