Abstract rnBackground: Several development organizations have argued that clinical trials (CTs) inrnLMICs are crucial for advancing public health and development. In order to ensure thatrnclinical trials facilities (CTFs) can respond to this demand, it is vital that a country hasrnsufficient capacity in various aspects including infrastructure to conduct CTs. Despite,rndifferent capacity challenges that affecting research systems in LMICs have been recognized;rnsubstantial amount of this evidence is inferred from experiences with specific institutions orrnprogrammes and does not build on systematic baseline data and conceptual frameworks.rnFurthermore, CTs funders are increasingly looking for evidence that investigators are linkedrnto CTFs with sufficient expertise and infrastructure, so it is critical that the prevailingrncapacity of this resource is assessed and the need for any further capacity strengthening isrnidentified. rnObjective: To assess existing capacity of conducting clinical trials, perceived gaps andrnpriorities for capacity strengthening for CTFs in Ethiopia. rnMethods: An institutional-based cross-sectional situational analysis was carried out usingrnmixed methods approaches: online semi-structured interviews with key informants, documentrnreview, and an email-based, self-administered checklist of key domains of CTs infrastructurernand capacity. The data was collected from September-November 2020. Descriptive statisticalrnmethods were used to summarize quantitative data. Qualitative data were transcribedrnverbatim and analyzed using a framework approach. NVivo software version 12 (QSRrnInternational Pty Ltd.) was used to manage qualitative data Findings from quantitative andrnqualitative study components were triangulated. rnResults: Of the 27 CTFs currently conducting drug trials in Ethiopia, 13 (48% response rate)rnresponded to at least one assessment, 7 responded to both assessments, 3 responded only tornthe quantitative questionnaire and 3 responded only to qualitative interview. The results fromrnthe 10 CTFs who responded to the quantitative assessment indicated that they had 159 staffrnlinked to the CTF, comprising 112 (70.4%) of the scientific staff and 47 (29.6%) supportrnstaff. Among the 10 leading causes of death in Ethiopia, only two were included in the trialrnportfolio of the CTFs. A total of 35 CTs had been conducted in the 10 CTFs, with 46% ofrnthese being locally developed protocols and phase III trials. Two CTFs reported ownership ofrnresearch laboratory and data management units with external certification. Onsite monitoringrnwas used by most CTFs, but the indicators that were monitored varied across the CTFs.rnSynthesis of nine key informant interviews highlighted the current capacity challenges,rnidentified priority areas to develop capacity and the factors affecting availability of CTF fundsrnand the sustainability of CTFs infrastructure. rnConclusions: This study has identified that Ethiopian CTFs have limited capacity tornconduct CTs due to a lack of physical infrastructure, workforce, CTs experiences, and datarnmanagement, as well as a lack of institutional structures to support CTs at various levels.rnFurthermore, a number of priority areas for capacity development have been identified,rncalling for a coordinated effort of different stakeholders and funders.