From Adaptive Licensing to Adaptive Pathways: Delivering a Flexible Life-Span Approach to Bring New Drugs to Patients
From Adaptive Licensing to Adaptive Pathways: Delivering a Flexible Life-Span Approach to Bring New Drugs to Patients
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DOI：
10.1002/cpt.59
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发表时间：
2015-03-01
影响因子：
6.7
通讯作者：
Hirsch, G.
中科院分区：
文献类型：
--
作者：
Eichler, H-G;Baird, L. G.;Hirsch, G.
适应性许可（AL）的概念已经引起了相当大的兴趣。然而，一些人仍然对其可行性持怀疑态度。另一些人认为，AL的重点和名称应该扩大。在这种持续辩论的背景下，我们研究了环境变化，这可能使适应性途径成为未来的首选方法。主要驱动因素包括：患者对及时获得有希望的疗法的需求不断增长，新兴科学导致治疗人群的碎片化，付款人对产品可及性的影响不断增加，制药公司/投资者面临确保药物开发可持续性的压力。我们还讨论了一些环境的变化，将使一个适应性的范例。将创新带给患者的生命周期方法预计将有助于解决感知的访问与证据权衡，帮助降低药物开发风险，并为患者带来更好的结果。
The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.