What question did this study set out to answer?

To develop guidance that supports stakeholder deliberation on the systematic identification, categorization, and mitigation of decision-relevant uncertainties across the drug regulatory and health technology assessment interface.

January 1, 2023International Journal of Technology Assessment in Health CareOpen Access

Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group

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Authors

MHMilou A. HogervorstUtrecht University RVRick A. VremanUtrecht University IHInkatuuli HeikkinenLundbeck (Germany)

Discussion

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Implication

Expert consensus report reveals a structured taxonomy to identify drug decision uncertainties in regulatory and health technology assessment, highlighting improved consistency in drug access.

Key Points

To develop guidance that supports stakeholder deliberation on the systematic identification, categorization, and mitigation of decision-relevant uncertainties across the drug regulatory and health technology assessment interface.
Convened an interdisciplinary working group conducting six online consensus discussions between December 2021 and September 2022.
Synthesized findings from a scoping review, a survey, two literature-based case studies, a real-world case study, and two international conference panel discussions.
Identified 12 core building blocks of uncertainty that were translated into an evaluative checklist to determine whether an issue constitutes a decision-relevant uncertainty.
Developed a domain taxonomy across the regulatory-health technology assessment interface to categorize evidence gaps, demonstrating deliberation utility via a real-world case study.

Cite This Study

Hogervorst et al. (2023) studied this question.

synapsesocial.com/papers/69fe4e7b636be799ce553ac3 https://doi.org/10.1017/s0266462323000375

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Implication

Expert consensus report reveals a structured taxonomy to identify drug decision uncertainties in regulatory and health technology assessment, highlighting improved consistency in drug access.

Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group

Discussion

Member takes

Implication

Key Points

Cite This Study

Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group

Discussion

Member takes

Implication

Key Points

Cite This Study

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