重新思考临床研究协议:从COVID-19大流行中吸取的经验教训以及减少违规行为的建议
Matthew J Gooden1, Gina Norato1, Katherine Landry1
1Clinical Trials Unit, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
Clinical trials (London, England)
|February 17, 2024
概括
随着COVID-19大流行,临床试验不合规率显著增加,影响了参与者的安全性和数据有效性. 协议需要更新以管理环境变化并确保数据完整性.
科学领域:
- 临床试验 临床试验
- 研究方法研究方法研究方法学
- 公共卫生 公共卫生
背景情况:
- 截至2023年11月,COVID-19大流行病在全国范围内造成超过1.03亿例病例和110万例死亡.
- 实施了缓解措施,但它们对临床试验参与者安全的影响仍未充分记录.
研究的目的:
- 评估COVID-19大流行对临床试验中不合规率的影响.
- 分析违规事件的特征,特别是与COVID-19限制有关的事件.
主要方法:
- 从2019年7月到2021年8月的不合规事件的回顾性分析.
- 事件按日期分层 (COVID-19前和后的限制).
- 详细描述事件的规模,地点,类型,类别和原因,并对COVID-19相关的不合规行为进行具体分析.
主要成果:
- 在35个协议和21,146名参与者中,共记录了323起违规事件.
- 整体违规率显著增加,从每名参与者限制后的0.008到0.022事件 (p < 0.001).
- 与COVID-19相关的事件主要是轻微的 (99%),程序性 (99%),并涉及不完整的研究访问 (77%).
结论:
- 违规事件对参与者安全和试验数据有效性构成风险.
- 临床试验协议需要修订,以更好地捕捉外部环境变化中的安全性和有效性数据.
- 试验协议的积极适应对于在不可预见的情况下保持数据完整性至关重要.
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