临床试验的去中心化和以患者为中心:好处和挑战
Shubhadeep D Sinha1, Sreenivasa Chary Sriramadasu2, Ruby Raphael2
1Department of Clinical Development and Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, 500018, India. SD.Sinha@hetero.com.
Pharmaceutical medicine
|March 7, 2024
概括
分散临床试验 (DCT) 通过尽量减少现场访问来提高患者参与率和降低退学率. 这种以患者为中心的方法可以加速药物开发和进入市场.
科学领域:
- 临床研究 临床研究
- 制药科学 制药科学
- 医疗信息学 医疗信息学
背景情况:
- 分散临床试验 (DCT),也称为虚拟或远程试验,旨在改善患者的可访问性.
- 传统的临床试验往往需要大量的患者旅行,导致高的学率和延迟.
- 随着COVID-19的流行,DCT的采用和监管接受加速了.
研究的目的:
- 突出DCT在提高患者中心性和试验效率方面的好处.
- 讨论数字技术在促进远程数据收集和患者参与方面的作用.
- 为了强调DCT在现代药物开发中的日益重要.
主要方法:
- DCT利用一系列数字技术进行远程数据收集和参与者参与.
- 该方法涉及尽量减少或消除患者前往试验场所的需要.
- 采用了结合远程和面对面程序的混合模型.
主要成果:
- 临床临床试验表明,参与者学率有所降低,研究效率有所提高.
- 以患者为中心的模型提高了方便性和参与度,从而带来了更好的现实数据.
- 实现了更快的药物开发时间表,并为赞助商节省了大量的成本.
结论:
- 分散和以患者为中心的方法是临床试验未来的组成部分.
- 美国FDA和EMA等监管机构正在更新指南,以支持DCT.
- 制药公司应该采用DCT来简化药物开发,并优先考虑患者的需求.
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