To date, there has been little agreement in the literature on what exactly constitutes radical drug innovation and how to properly measure this important construct. Without a validated measure, our ability to understand radical drug innovations, explain their origins, and demonstrate their implications for management and health policy is limited. This paper addresses the problem of radical drug innovation measurement, provides evidence of the limitations associated with the current state of the art, and offers a new method based on German health technology assessments (HTA). Data was obtained for 147 drugs authorized by the European Medicines Agency from 2011 to 2016. The innovativeness of these drugs was assessed using current measures of radical drug innovation compared with the newly developed measure. Findings indicate that current measures of radical drug innovation are associated with very inconsistent outcomes and do not appear to measure what they purport to measure. This study argues that assessing therapeutic value (as measured by the German HTA) is particularly important, given that drug novelty alone does not conclusively indicate whether a drug will deliver therapeutic value.

中文翻译：

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当前的激进创新措施是否真正衡量了激进的药物创新？

迄今为止，关于激进药物创新的确切构成以及如何正确衡量这一重要结构，文献中几乎没有达成一致。如果没有经过验证的衡量标准，我们理解激进药物创新、解释其起源以及证明其对管理和卫生政策的影响的能力是有限的。本文解决了激进药物创新测量的问题，提供了与当前技术状态相关的局限性的证据，并提供了一种基于德国卫生技术评估 (HTA) 的新方法。获得了 2011 年至 2016 年欧洲药品管理局授权的 147 种药物的数据。这些药物的创新性是使用当前的激进药物创新措施与新制定的措施进行比较评估的。调查结果表明，当前对激进药物创新的衡量标准与非常不一致的结果相关，并且似乎无法衡量他们声称要衡量的内容。本研究认为，评估治疗价值（由德国 HTA 衡量）尤为重要，因为仅凭药物新颖性并不能最终表明药物是否具有治疗价值。