Development, implementation, and evaluation of an innovative clinical trial operations training program for Africa (ClinOps)

Abstract

Background Africa's involvement in clinical trials remains very low. Although the crucial role of training initiatives in building clinical trial capacity in Africa has been documented, current efforts fall short as they lack alignment with local contexts. This study aimed to design, develop, implement, and evaluate an innovative clinical trial operations training program for Africa. Methods We developed ClinOps, a novel 10-week clinical trial operations training program for study coordinators in Africa, intending to enhance their expertise in four fundamental areas: designing, conducting, managing, and reporting clinical trials. We used cloud applications to minimize installation of software, whilst maximizing student engagement with the course, VoiceThread, an interactive collaboration and sharing tool allowed interactive content to be accessed offline. Moodle, an open-source learning management system provided a platform to share learning tools, provide one-on-one mentorship, and multidirectional competency assessment strategies including lesson quizzes, forum discussions, asynchronous tutorials, and group assignments. We used Zoom video conferencing application for live tutorials and mentoring, as required. Program effectiveness was evaluated through quantitative pre-post tests, qualitative end-course evaluations, and a comprehensive monitoring and evaluation. We used Wilcoxon rank test to compare pre-post test scores and thematic analysis to analyze the qualitative data. Results In the initial cohort, 88 study coordinators from 19 countries participated, including 56 (64%) females, with 57 (65%) actively employed as study coordinators during the training, and 85 (97%) possessing prior experience in clinical trial roles. Among these, 71 (81%) successfully completed the course, with 69 (97%) also completing the post-course assessment. Post-training scores demonstrated substantial improvement compared to pre-training scores in each competency area, including in designing (mean rank = 36.27 vs 12.20; Z = 6.799, p < 0.001), conducting (mean rank = 31.78 vs 8.0; Z = -6.68, p < 0.001), managing (mean rank = 36.89 vs 9.83; Z = -6.813, p < 0.001), and reporting (mean rank = 16.94 vs 3.0; Z = -4.897, p < 0.001) clinical trials. The program adhered to training best practices, encompassing alignment with local priorities, country ownership, pedagogic innovation, institutional capacity building, sustainability, and ongoing partnerships. Participants acknowledged the program for its structure, content, relevance to their current roles, and the overall delivery methods. Conclusion The ClinOps program, a clinical trial operations training initiative for Africa developed by experts from academia and product development partners, significantly enhanced participants' competency in clinical trials. Transferring the program to a local institution promoted country ownership and established the local partner institution as a sustainable clinical trial training hub for Africa. To effectively build clinical trials capacity in Africa, training initiatives should offer comprehensive competency in designing, conducting, managing, and reporting trials tailored to local contexts.