Integrating Early Economic Evaluation into Target Product Profile development for medical tests: advantages and potential applications
Integrating Early Economic Evaluation into Target Product Profile development for medical tests: advantages and potential applications
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DOI：
10.1017/s0266462321000374
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发表时间：
2021-06-07
影响因子：
3.2
通讯作者：
Shinkins，Bethany
中科院分区：
文献类型：
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作者：
Cocco，Paola;Messenger，Michael Paul;Shinkins，Bethany
目标产品简介（TPP）概述了新的卫生技术需要解决未满足的临床需求的特征。迄今为止，已公布的医学检测技术方案伙伴关系侧重于传染病，主要是在低收入和中等收入国家。最近，有人呼吁更广泛地使用TPP作为一种机制，以确保诊断创新与临床需求保持一致，但TPP开发的基础方法仍然不理想。在这里，我们建议，早期经济评估（ESTA）应纳入TPP的方法，以创建一个更严格的框架，为发展“适合目的”的测试。我们讨论了潜在的好处，可带来的核心活动，支持TPP的发展范围，起草，建立共识，并更新，并认为，使用可持续发展，以帮助通知TPP提供了一个更客观，以证据为基础的，和透明的方法来定义测试规格。
Target Product Profiles (TPPs) outline the characteristics that new health technologies require to address an unmet clinical need. To date, published TPPs for medical tests have focused on infectious diseases, mostly in the context of low- and middle-income countries. Recently, there have been calls for a broader use of TPPs as a mechanism to ensure that diagnostic innovation is aligned with clinical needs, yet the methodology underpinning TPP development remains suboptimal. Here, we propose that early economic evaluation (EEE) should be integrated within the TPP methodology to create a more rigorous framework for the development of “fit-for-purpose” tests. We discuss the potential benefits that EEE could bring to the core activities underpinning TPP development—scoping, drafting, consensus building, and updating—and argue that using EEE to help inform TPPs provides a more objective, evidence-based, and transparent approach to defining test specifications.