Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
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DOI：
10.1002/cpt.509
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发表时间：
2016-12-01
影响因子：
6.7
通讯作者：
Selker, H.
中科院分区：
文献类型：
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作者：
Hirsch, G.;Trusheim, M.;Selker, H.
当前的生物医学创新体系无法跟上科学进步的步伐。我们建议通过重新设计创新流程来解决这一差距，以加速可靠地交付产品，满足未满足的医疗需求。适应性生物医学创新 (ABI) 为流程创新提供了一种综合的战略方法。尽管ABI这个术语是新的，但它包含了全球制药行业开发的碎片化工具，并且可以通过更协调的应用来加速系统的演进。 ABI 涉及将利益相关者聚集在一起，设定共同目标、培养信任、构建决策并通过快速循环反馈循环管理期望，从而最大限度地提高产品知识并减少持续、适应性和可持续学习医疗保健系统中的不确定性。自适应决策是 ABI 的核心要素，它提供了一个构建决策的框架，旨在管理两种类型的不确定性——科学和临床知识的成熟度，以及其他关键利益相关者的行为。
The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although the term ABI is new, it encompasses fragmented tools that have been developed across the global pharmaceutical industry, and could accelerate the evolution of the system through more coordinated application. ABI involves bringing stakeholders together to set shared objectives, foster trust, structure decision-making, and manage expectations through rapid-cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable learning healthcare system. Adaptive decision-making, a core element of ABI, provides a framework for structuring decision-making designed to manage two types of uncertainty - the maturity of scientific and clinical knowledge, and the behaviors of other critical stakeholders.