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. 2016 Dec;100(6):685-698.
doi: 10.1002/cpt.509. Epub 2016 Oct 22.

Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need

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Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need

G Hirsch et al. Clin Pharmacol Ther. .
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Erratum in

Abstract

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.

Figures

Figure 1
Figure 1
Key elements of adaptive biomedical innovation (ABI).
Figure 2
Figure 2
Adaptive biomedical innovation (ABI) stakeholder decision factors and uncertainties. ABI relies on the participation of diverse stakeholder groups, aiming to deliver better, affordable treatments to the right patients faster, in ways that work for all stakeholders. Shown are selected roles of six key stakeholders, with examples of factors that impact their decisions about a medical product, including examples of uncertainties that may enter into the decision processes. HTA, health technology assessment; RCT, randomized controlled trial.
Figure 3
Figure 3
Adaptive decision‐making in adaptive biomedical innovation (ABI). ABI seeks to empower appropriate and timely patient access to new therapies by using iterative decision‐making that is governed by stakeholder agreed adaptation plans that flexibly manage dynamic uncertainties in knowledge about clinical and scientific aspects of the therapies and the behavior of key stakeholders. The two key outcomes, patient access and an adaptation plan, are shown in red. Multistakeholder interactions across all elements are important for the effective design and implementation of adaptive decision‐making.
Figure 4
Figure 4
Patient access decision toolkit.
Figure 5
Figure 5
Uncertainties addressed in the adaptation plan.
Figure 6
Figure 6
Knowledge matrix for a traditionally developed therapeutic. Each domain has uncertainties including parameters to track, measurement precision, and required effect size. HTA, health technology assessment; RCT, randomized clinical trial; REMs, risk evaluation and mitigation strategies.
Figure 7
Figure 7
The biomedical innovation lifespan for a single product and multiple indications, with traditionally developed knowledge. On the top, a single‐product indication across lifespan. Lower, the complexity of multiple indications over time with generic entries and additional studies or reports of safety, effectiveness and value. This complexity may be boosted by a lack of interaction among stakeholders.
Figure 8
Figure 8
Knowledge matrix for adaptive biomedical innovation (ABI). This approach improves knowledge quality and quantity over all four domains and connects across the knowledge stages to create a learning biomedical innovation system.

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