Scholarlink

Background <p>The East African Community (EAC) has experienced a significant increase in volume and complexity of clinical research driven by the epidemics of emerging and re-emerging infectious diseases such as HIV, Ebola, COVID-19, and mpox. This demands for robust research, scientific, and ethical oversight. We aimed to strengthen the capacity of national research regulatory authorities (NRRA), research ethics committees (RECs), and researchers for review and oversight of studies with complex and emerging designs.</p> Methods <p>We implemented a blended training program from February 2024 to February 2025 in six EAC partner states, including; republic of Burundi, republic of Kenya, republic of Rwanda, republic of South Sudan, republic of Tanzania, and republic of Uganda. Trainees were evaluated using pre and post-training assessments, and also provided qualitative responses.</p> Results <p>A total of 186 participants completed the training, of which 59.0% (110/186) were males<b>.</b> Participants demonstrated a marked improvement in knowledge, with mean scores increasing from 52.9% at pre-test to 84.0% at post-test, and the proportion of participants that passed increased from 18.1% (34/186) at pre-test to 84.2% (157/186) at post-test. Three main themes emerged from the open-ended response evaluations: (1) enhanced understanding of emerging and complex study designs, (2) relevance to professional roles and practice, and (3) demand for advanced methodological training.</p> Conclusions <p>There was a substantial shift in knowledge on emerging and complex research study designs. We recommend regular training of NRRA and REC members to improve the quality of review of research protocols with complex and emerging study designs.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Strengthening research regulatory capacity in the East African community: a multi-country training program on emerging and complex study designs

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月2日

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

摘要

Background

The East African Community (EAC) has experienced a significant increase in volume and complexity of clinical research driven by the epidemics of emerging and re-emerging infectious diseases such as HIV, Ebola, COVID-19, and mpox. This demands for robust research, scientific, and ethical oversight. We aimed to strengthen the capacity of national research regulatory authorities (NRRA), research ethics committees (RECs), and researchers for review and oversight of studies with complex and emerging designs.

Methods

We implemented a blended training program from February 2024 to February 2025 in six EAC partner states, including; republic of Burundi, republic of Kenya, republic of Rwanda, republic of South Sudan, republic of Tanzania, and republic of Uganda. Trainees were evaluated using pre and post-training assessments, and also provided qualitative responses.

Results

A total of 186 participants completed the training, of which 59.0% (110/186) were males. Participants demonstrated a marked improvement in knowledge, with mean scores increasing from 52.9% at pre-test to 84.0% at post-test, and the proportion of participants that passed increased from 18.1% (34/186) at pre-test to 84.2% (157/186) at post-test. Three main themes emerged from the open-ended response evaluations: (1) enhanced understanding of emerging and complex study designs, (2) relevance to professional roles and practice, and (3) demand for advanced methodological training.

Conclusions

There was a substantial shift in knowledge on emerging and complex research study designs. We recommend regular training of NRRA and REC members to improve the quality of review of research protocols with complex and emerging study designs.