为非洲 (ClinOps) 开发,实施和评估一项创新的临床试验操作培训计划
Dawit Asmamaw Ejigu1,2, Abebaw Fekadu3,4, Jeremy Whitty5,6
1Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, P.O. Box 9086, Addis Ababa, Ethiopia. dawit.a.ejigu@cdt-africa.edu.et.
BMC medical education
|January 25, 2025
概括
这项临床试验操作培训计划ClinOps显著提高了非洲研究协调员在设计,进行,管理和报告试验方面的技能. 该计划在整个非洲大陆建立必要的临床试验能力方面取得了成功.
科学领域:
- 临床研究行动临床研究行动.
- 医疗培训和教育是医学培训和教育.
- 全球卫生倡议 全球卫生倡议
背景情况:
- 非洲参与临床试验的比例特别低.
- 现有的培训举措缺乏与当地环境的调整,阻碍了能力建设.
- 在非洲需要相关的临床试验操作培训.
研究的目的:
- 设计,开发,实施和评估针对非洲量身定制的创新临床试验操作培训计划.
- 提高非洲研究协调员在关键试验阶段的专业知识:设计,实施,管理和报告.
- 为了利用技术来提供可访问和引人入胜的临床试验培训.
主要方法:
- 开发了一个为期10周的"ClinOps"计划,使用基于云的工具 (VoiceThread,Moodle,Zoom) 进行交互式,可访问的学习.
- 员工前后调查以衡量信心和技能的变化,并进行定性最终课程评估.
- 使用Wilcoxon排名测试用于定量数据和主题分析用于定性反.
主要成果:
- 来自19个非洲国家的88名研究协调员参与了这项研究,完成率为81%.
- 在所有能力领域观察到显著的改善:设计,进行,管理和报告临床试验 (p < 0.001).
- 项目评估证实了遵守最佳实践,并获得了参与者对内容和交付的积极反.
结论:
- ClinOps计划有效地提高了非洲参与者的临床试验能力.
- 关于试验设计,进行,管理和报告的全面培训对于建立非洲临床试验能力至关重要.
- 这一创新计划是未来非洲临床研究能力建设工作的典范.
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