加强东非社区的研究监管能力:关于新兴和复杂的研究设计的多国培训计划
Mathius Amperiize1, Belinda Twesigye1, Beth Mutumba2
1Infectious Diseases Institute, Kampala, Uganda.
培训显著提高了东非监管机构和伦理委员会对复杂的临床研究设计的了解. 建议定期建立能力,以加强对新兴传染病研究的监督.
科学领域:
- 临床研究监督 临床研究监督
- 公共卫生准备情况 公共卫生准备情况
- 传染病流行病学 传染病流行病学
背景情况:
- 由于传染病流行病 (艾滋病毒,埃博拉,COVID-19,mopox) 的原因,东非社区面临临临床研究复杂性的增加.
- 强有力的科学和道德监督对于管理复杂的研究设计至关重要.
- 需要为国家研究监管机构 (NRRA) 和研究伦理委员会 (REC) 建立能力.
研究的目的:
- 加强东非共同体的NRRA,REC和研究人员的能力.
- 改善涉及复杂和新兴研究设计的研究的审查和监督.
- 为满足该地区临床研究日益增长的需求.
主要方法:
- 从2024年2月到2025年2月,在6个东非伙伴国家进行了混合培训计划.
- 参与者包括NRRA,REC和研究人员的成员.
- 评估包括培训前后的评估和定性反.
主要成果:
- 186名参与者完成了培训,知识分数显著提高 (52.9%至84.0%).
- 通过率从培训后的18.1%增加到84.2%.
- 来自反的关键主题包括对复杂设计的更好理解,与实践的相关性以及对高级培训的需求.
结论:
- 培训的结果是对新兴和复杂的研究研究设计的知识大幅增加.
- 建议对NRRA和REC成员进行定期培训,以提高研究协议审查的质量.
- 加强监管和道德监督对于推动东非临床研究至关重要.
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