Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
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DOI：
10.1177/2168479013487355
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发表时间：
2013-07-01
影响因子：
1.5
通讯作者：
Hirsch, Gigi
中科院分区：
文献类型：
--
作者：
Baird, Lynn G.;Trusheim, Mark R.;Hirsch, Gigi
本研究评估了与目前广泛使用的方法相比，药物开发的适应性开发和许可方法是否可能在利益相关者群体中具有切实的优势，从而促进未来的采用。涉及3个病例研究的实际和模拟临床开发和许可计划的详细信息用作贴现现金流电子表格模型的输入。输出包括净现值和预期净现值（被视为药品开发商的关键激励指标），以及产品生命周期内患者可及性的变化以及适当和不适当治疗的患者数量（被视为监管机构、患者和处方者的关键激励指标）。实际和建模的开发程序进行了比较，使用自适应评分算法。一般来说，更具适应性的计划与更有利的利益相关者的结果。然而，在某些情况下，有利的结果可能会被淹没，需要定义因果条件和利益相关者的反应。
This study evaluates whether an adaptive development and licensing approach to drug development, compared with approaches widely used today, might have tangible advantages across stakeholder groups, thereby facilitating the future adoption. Details involving actual and modeled clinical development and licensing programs for 3 case studies were used as inputs into a discounted cash flow spreadsheet model. Outputs included net present value and expected net present value, which are metrics considered as key incentives for pharmaceutical developers, and change in patient access over the product life and numbers of appropriately and inappropriately treated patients, which are metrics considered as key incentives for regulators, patients, and prescribers. Actual and modeled development programs were compared using an adaptiveness scoring algorithm. Generally, the more adaptive programs correlated with more favorable stakeholder outcomes. However, favorable outcomes may be overwhelmed in some cases, and the causative conditions and stakeholder reactions need to be defined.