一项试验中的研究,评估补充,加强基于风险的培训,以减少儿科多中心随机对照试验中的实施障碍
Danielle J Green1, Valeriya Vasenina2, Kelsee Meyerhoffer1
1Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, United States of America.
Contemporary clinical trials
|March 16, 2026
概括
补充,加强,基于风险的培训 (SRRBT) 显示了改善早期临床试验协议遵守的潜力. 然而,持续的好处需要持续加强,以保持复杂的研究环境中的高标准.
科学领域:
- 临床试验 临床试验
- 医学教育 医学教育
- 研究诚信研究诚信
背景情况:
- 标准的临床试验人员培训方法在具体性和长期影响方面存在局限性.
- 确保数据完整性和参与者安全需要严格遵守协议.
- 一个补充,加强,基于风险的培训 (SRRBT) 计划被开发出来,以应对研究特定的挑战,并提供持续的加强.
研究的目的:
- 评估SRRBT计划在改善临床试验场所之间的协议遵守方面的有效性.
- 评估SRRBT是否提高了参与研究的合格参与者的比例.
主要方法:
- 一个集群随机化的教育实施研究,嵌入多中心临床试验.
- 在23个临床场所进行的标准培训与标准培训加SRRBT的比较.
- SRRBT使用了五个交互式电子图片,重点关注试验特定能力;主要结果是参与者接近率.
主要成果:
- 使用SRRBT的网站显示,在培训后立即出现更高的参与者接触率 (OR=3.98),尽管在统计学上并不显著.
- 这一最初的趋势随着时间的推移而减弱,六个月后的2.24和12个月后的1.38的非显著赔率比率.
- 还评估了二次结果,如同意,入学,偏差和文档完整性.
结论:
- 在临床试验中,SRRBT显示了改善临床试验早期现场级协议遵守的潜力.
- 维持SRRBT的好处可能需要持续的强化策略.
- 该研究强调了在复杂的临床试验中需要持续的,适应性的培训方法.
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