添加人群的影响 (),干预,比较器 (),以及欧洲联合临床卫生技术评估中的结果
Anke van Engen1, Robert Krüger2, Adam Parnaby3
1Real World Solutions, IQVIA, Amsterdam, The Netherlands.
概括
欧洲卫生技术评估网络 (EUnetHTA) 对人口,干预,比较器和结果 (PICOs) 的指导产生了大量分析. 简化PICO开发对于欧盟成员国的高效,有影响力的医疗技术评估至关重要.
科学领域:
- 卫生技术评估 卫生技术评估
- 制药政策 制药政策
- 在瘤学瘤学.
背景情况:
- 欧洲卫生技术评估网络 (EUnetHTA) 为制定人口,干预,比较和结果 (PICO) 标准提供了指导.
- 标准化的PICO开发对于在欧盟成员国 (MS) 进行一致的医疗技术评估 (HTA) 是必不可少的.
研究的目的:
- 评估由EUnetHTA 21 PICO指南产生的分析数量.
- 探索创建更可预测和可操作的欧盟PICOs的方法,用于医疗技术评估.
主要方法:
- 根据现有的HTA报告,在第一线非小细胞肺癌 (1L NSCLC) 和第三线多发性骨髓瘤 (3L MM) 中获得了假设药物的合并欧盟PICO.
- 根据EUnetHTA 21指南,估计了所需的分析数量,并通过敏感性分析评估了额外的PICO请求的影响.
主要成果:
- 对于1L NSCLC和3L MM的合并PICO分别为10和16 (随着额外的范围增加到14和18).
- 对于这些适应症,至少需要280和720个分析,对于额外的结果或子组,需要指数级增加.
结论:
- 由于大量的分析请求,EUnetHTA 21 PICO方法需要大量的资源.
- 采用互补的,基于证据的方法和与开发商的早期接触可以产生可预测的,有影响力的欧盟PICO,以便及时和可用的HTA报告.
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