Ther Innov Regul Sci. 2026 Apr 27. doi: 10.1007/s43441-026-00973-5. Online ahead of print.
ABSTRACT
BACKGROUND: Sub-Saharan Africa carries 25.0% of the global disease burden but hosts only 2.0% of clinical trials worldwide. A key measure to address this challenge is shortening review timelines and enhancing the capacity of protocol reviewers in regulatory authorities. This study, triggered by the Tanzania medicines and medical devices authority and stakeholders, aimed to assess the competency of assessors in reviewing clinical trial applications and to conduct an intervention involving didactic and hands-on training.
METHODS: A descriptive cross-sectional study was conducted from February 2021 to June 2021 using an online survey targeting 128 participants from medicines regulatory authorities, regional ethical committees, institutional review boards, and research institutions. A 70-hour (7 credit) course was developed and implemented in 30 clinical trial assessors.
RESULTS: The survey had a 70.3% response rate, with 58.9% male participants. Over half of the participants held a master’s degree. The study revealed that 94.0% needed training in clinical assessment, 92.2% in quality assessment, and 92.6% in statistical assessment for clinical trial protocols. Following pre- and post-training evaluation, one sample t-test indicated a statistically significant difference in the mean scores, 18.96, CI (13.15-24.76), indicating an improvement in the knowledge of the participants.
CONCLUSION: The study identified significant gaps in the competency of clinical trial applications assessors and ethical reviewers in Tanzania according to the African vaccine regulatory forum guidelines for review of clinical trial protocols. The targeted training improved the capacity of 30 assessors, yet further targeted and stratified capacity-building trainings are recommended to enhance regulatory capacity.
PMID:42036537 | DOI:10.1007/s43441-026-00973-5
