The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream

Reaney, Matthew, Bush, Elizabeth, New, Mary, Paty, Jean, de Climens, Aude Roborel, Skovlund, Soren E, Nelsen, Linda, Flood, Emuella and Gater, Adam (2018) The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream. Therapeutic innovation & regulatory science, 53 (5). pp. 630-638. ISSN 2168-4804

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Abstract

Benefit-risk assessment is the cornerstone of decision making in medical care, playing a critical role in bringing treatments to market by informing decisions regarding drug development, licensing and reimbursement, and informing treatment decisions made by health care professionals and patients in clinical practice. In regulatory approval decision making, benefit and risk attributes are identified and defined based on available, aggregated clinical data from registration trials. In the context of major developments in recent years for involvement of patients as partners in all phases of drug development and in health care improvement, decision makers increasingly recognize the importance of informing treatment decisions by patient needs, values, experiences, and preferences. Using this as a basis, a DIA workstream was convened to explore the potential of individual-level benefit-risk assessment as a supplement to traditional group-level benefit-risk assessment for evaluating treatment. Various approaches as to how this information could be collected, including via patient-reported outcome measures, open-ended questioning, and stated-preference methods are presented. The utility of this information for various stakeholders is discussed.

Item Type: Article
Uncontrolled Keywords: benefit-risk, clinical outcome assessments, patient preference, patient-centricity, patient-reported outcomes, Public Health, Environmental and Occupational Health, Pharmacology (medical), Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Subjects: B Philosophy. Psychology. Religion > B Philosophy (General)
B Philosophy. Psychology. Religion > BF Psychology
H Social Sciences > H Social Sciences (General)
Divisions: Departments > Psychology and Counselling
SWORD Depositor: Publications Router Jisc
Depositing User: Publications Router Jisc
Date Deposited: 09 Nov 2018 15:30
Last Modified: 05 Sep 2019 13:36
URI: http://eprints.chi.ac.uk/id/eprint/3964

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