设计和执行可持续的分散的临床试验
Pritibha Singh1,2, Andrea M Burden2,3, Fanni Natanegara4
1Novartis Pharma AG, Basel, Switzerland.
Clinical pharmacology and therapeutics
|July 25, 2023
概括
分散临床试验 (DCT) 通过在家监测患者来加速治疗发展. 目前的指导方针缺乏全面的可持续性评估,特别是对环境影响的评估.
科学领域:
- 临床研究 临床研究
- 医疗卫生技术 技术 技术
- 监管科学 监管科学
背景情况:
- 分散临床试验 (DCT) 利用技术进行远程患者监测,提高效率和患者的便利性.
- 通过在患者的日常环境中捕获真实世界的数据,DCT比传统试验提供了优势.
- 现有的DCT框架和指导正在不断发展,但需要进一步发展.
研究的目的:
- 对设计和执行DCT的现有框架和指导进行差距分析.
- 确定当前指南不足以全面实施DCT的领域.
- 突出需要在DCT设计中加强可持续性评估.
主要方法:
- 采用叙事审查方法来分析专家组和监管机构的框架和指导.
- 一个由八个要素组成的框架 (合适性,协议,IMP供应,调查人员,安全,监管/伦理,数据/技术,参与) 指导了差距分析.
- 分析的重点是确定与DCT的设计和执行有关的指导方面的差距.
主要成果:
- 差距分析显示,需要对DCT所有元素进行全面的可持续性评估.
- 目前的指导方针充分解决了社会可持续性,部分解决了经济可持续性.
- 在指导环境可持续性方面存在重大差距,包括碳足迹和材料的处置.
结论:
- DCT代表了医疗保健研究的关键进步,提供了加速的治疗开发.
- 迫切需要更全面的指导来评估和确保DCT的可持续性.
- 未来的指导应该在DCT框架内优先考虑环境可持续性考虑.
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