Use of Patient Preferences Data Regarding Multiple Risks to Inform Regulatory Decisions

Overview

Journal MDM Policy Pract

Publisher Sage Publications

Specialty General Medicine

Date 2023 Jan 19

PMID 36654678

Authors

J Felipe Montano-Campos

Juan Marcos Gonzalez

Timothy Rickert

Angelyn O Fairchild

Bennett Levitan

Shelby D Reed

Affiliations

Soon will be listed here.

Abstract

Highlights: Estimates of maximum acceptable risk (MAR) for a defined treatment benefit can be useful to inform regulatory decisions; however, the conventional metric considers one adverse event at a time.This article applies a new approach known as SMART (simultaneous maximum acceptable risk thresholds) that accounts for multiple adverse events to 3 published discrete-choice experiments.Findings reveal that conventional MARs could lead decision makers to accept a treatment based on individual risks that would not be acceptable if multiple risks are considered simultaneously.

Citing Articles

Measuring Patient Preferences to Inform Clinical Trial Design: An Example in Rheumatoid Arthritis.

Currie G, Storek J, MacDonald K, Hazlewood G, Durand C, Bridges J Patient. 2024; 18(2):161-171.

PMID: 39666176 DOI: 10.1007/s40271-024-00724-4.

Method for Calculating the Simultaneous Maximum Acceptable Risk Threshold (SMART) from Discrete-Choice Experiment Benefit-Risk Studies.

Fairchild A, Reed S, Gonzalez J Med Decis Making. 2022; 43(2):227-238.

PMID: 36326189 PMC: 9827493. DOI: 10.1177/0272989X221132266.

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