欧洲联合临床评估 PICO 范围确定过程:分析当前的方法和建议
Kalpana D'Oca1, Eline Darquennes2, Chloé Garrigues3
1MSD (UK) Limited, London EC2M 6UR, UK.
Journal of market access & health policy
|January 23, 2026
概括
模拟欧盟联合临床评估 (JCA) 的PICO范围有助于卫生技术开发商 (HTD) 准备提交. 然而,有限的现实数据和模拟结果强调了在JCA PICO scoping中需要更清晰的整合流程.
科学领域:
- 卫生技术评估 卫生技术评估
- 监管科学 监管科学
- 在瘤学瘤学.
背景情况:
- 在欧盟医疗卫生评估条例 (EU HTAR) 下,PICO框架对于制定联合临床评估 (JCA) 范围至关重要.
- PICO整合是JCA范围确定过程中的关键,但不清楚的最后一步.
- 医疗技术开发人员 (HTD) 可以使用PICO范围模拟来战略性地指导JCA提交.
研究的目的:
- 在JCA中审查现有的PICO范围练习.
- 模拟特定瘤学指示的PICO测量,以了解实际挑战.
- 确定在JCA PICO范围和整合过程中需要更清晰的领域.
主要方法:
- 一项对详细介绍35项PICO练习的14篇出版物的系统审查,涉及20种适应症.
- 一个PICO范围模拟用于转移性非小细胞肺癌 (mNSCLC) 的一线免疫瘤治疗.
- 分析国家参与和综合PICOs的数量.
主要成果:
- 审查发现,每年平均有7个国家和8个合并PICO.
- 该mNSCLC模拟产生了67个PICO,反映了来自25个国家的预期观点,由子群体驱动.
- 有限的公布示例和模拟结果限制了关于JCA PICO范围可预测性的最终结论.
结论:
- 为了有效生成证据,需要在JCA PICO范围确定过程中提供更大的清晰度,特别是整合.
- 更清晰的流程将支持欧盟HTAR的效率,透明度,公平性和一致的患者获取目标.
- 这项研究提出了关于JCA中子群体的纳入和巩固的问题.
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