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Background <p>The expanding volume and increasing complexity of clinical research in East Africa, driven by emerging and re-emerging infectious diseases, has increased the need for strong regulatory monitoring systems. Clinical trials must be monitored to ensure regulatory compliance and participant safety. Despite strengthened regulatory and ethical frameworks in the region, gaps in trial monitoring persist due to a shortage of adequately trained monitors. This paper describes the design, implementation, and outcomes of a regional capacity-building initiative aimed at strengthening clinical trial monitoring capacity across six East African Community partner states.</p> Methods <p>We implemented a multi-country capacity-building project across six East African Community partner states: Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda. We conducted stakeholders’ consultations to identify the training needs that informed development of a tailored curriculum on clinical trial monitoring comprised of six modules, and approved by the Training Advisory Committee (TAC). We trained National Research Regulatory Authority (NRRA) personnel, Research Ethics Committee (REC) members, clinical researchers, and clinical trial monitors. The programme was implemented between February 2024 and February 2025, with one group per partner state. Each cohort completed a five-week blended learning programme comprising a two-day in-person workshop, four weeks of self-paced online learning, and a two-day virtual wrap-up session. Pre- and post-training assessments were administered to measure knowledge gain. Data were downloaded as CSV files, cleaned in Microsoft Excel, and exported to STATA 15.0 for analysis. Descriptive analyses were conducted and data summarized.</p> Results <p>We trained 200 participants, majority 30.5% (<i>n</i> = 61) of whom were from Uganda and 50.5% (<i>n</i> = 101) were female. Overall, mean knowledge scores increased significantly from 61.8% at pre-test to 84.3% at post-test (22.5% point improvement). The proportion of participants achieving the 60% pass mark increased from 37.5% (75/200) at pre-test to 95.6% (191/200) at post-test.</p> Conclusion <p>This capacity-building project showed a marked improvement in knowledge of clinical trial monitoring among NRRA personnel, REC members, clinical researchers, and clinical trial monitors across the EAC. Further studies should evaluate whether this knowledge gain translates into enhanced clinical trial monitoring and oversight practices.</p>

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Strengthening capacity for clinical trial monitoring in the East African community: a multi-country training programme

  • 期刊论文

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  • 发表日期：

    2026年6月16日

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  • Belinda Twesigye,
  • Mathius Amperiize,
  • Steve Wandiga,
  • Barbara Castelnuovo,
  • Stephen Okoboi,
  • Beth Mutumba,
  • Hellen Opolot,
  • Helen Ndagije,
  • Soazic Gardais,
  • Jeremiah Kidola,
  • Vincent Mutabazi,
  • Ramadhan Nyandwi,
  • Lina S. Mathew,
  • Novat Twungubumwe,
  • Provia Ainembabazi,
  • Pauline Byakika-Kibwika

摘要

Background

The expanding volume and increasing complexity of clinical research in East Africa, driven by emerging and re-emerging infectious diseases, has increased the need for strong regulatory monitoring systems. Clinical trials must be monitored to ensure regulatory compliance and participant safety. Despite strengthened regulatory and ethical frameworks in the region, gaps in trial monitoring persist due to a shortage of adequately trained monitors. This paper describes the design, implementation, and outcomes of a regional capacity-building initiative aimed at strengthening clinical trial monitoring capacity across six East African Community partner states.

Methods

We implemented a multi-country capacity-building project across six East African Community partner states: Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda. We conducted stakeholders’ consultations to identify the training needs that informed development of a tailored curriculum on clinical trial monitoring comprised of six modules, and approved by the Training Advisory Committee (TAC). We trained National Research Regulatory Authority (NRRA) personnel, Research Ethics Committee (REC) members, clinical researchers, and clinical trial monitors. The programme was implemented between February 2024 and February 2025, with one group per partner state. Each cohort completed a five-week blended learning programme comprising a two-day in-person workshop, four weeks of self-paced online learning, and a two-day virtual wrap-up session. Pre- and post-training assessments were administered to measure knowledge gain. Data were downloaded as CSV files, cleaned in Microsoft Excel, and exported to STATA 15.0 for analysis. Descriptive analyses were conducted and data summarized.

Results

We trained 200 participants, majority 30.5% (n = 61) of whom were from Uganda and 50.5% (n = 101) were female. Overall, mean knowledge scores increased significantly from 61.8% at pre-test to 84.3% at post-test (22.5% point improvement). The proportion of participants achieving the 60% pass mark increased from 37.5% (75/200) at pre-test to 95.6% (191/200) at post-test.

Conclusion

This capacity-building project showed a marked improvement in knowledge of clinical trial monitoring among NRRA personnel, REC members, clinical researchers, and clinical trial monitors across the EAC. Further studies should evaluate whether this knowledge gain translates into enhanced clinical trial monitoring and oversight practices.