在临床试验中重新定义可行性:合作方法,以改进选址的选择
Beau Bruneau1, Kristin Surdam2, Amy Bland3
1Florence Healthcare, USA.
Contemporary clinical trials communications
|August 6, 2024
概括
一个工作组确定了临床试验场所可行性的挑战,为赞助商,合同研究组织 (CRO) 和场所提出了最佳实践建议. 改善协作和数据标准化是更有效的试验的关键.
科学领域:
- 临床试验操作 临床试验操作
- 药学研究 药学研究
- 医疗保健管理的管理
背景情况:
- 临床试验过程面临着与现场可行性相关的重大挑战和负担.
- 成立了一个协作工作组来解决这些复杂问题.
研究的目的:
- 在赞助商,合同研究组织 (CRO) 和临床试验场所之间促进对现场可行性挑战的相互理解.
- 为加强合作和改善整体可行性过程提供可行的建议.
主要方法:
- 组建了一个多学科工作组,由赞助商,CRO和网站的代表组成.
- 该小组共同定义了可行性问题的范围,确定了当前的挑战,并进行了脑风暴改进策略.
主要成果:
- 确定需要在现场可行性的三个主要阶段和四个子阶段之间进行更清晰的区分.
- 突出了新兴趋势,例如早期启动现场可行性和过早的CRO参与.
- 对当前实践的分析揭示了对试验执行的下游影响,导致开发最佳实践指南.
结论:
- 工作组建议实践过程变化,并强调意识到新出现的趋势和相关风险.
- 整个行业的转型需要加强合作,数据标准化和自动化.
- 优化现场可行性过程为临床试验的效率和成功带来了巨大的好处.
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