A comparison of various aggregation functions in multi-criteria decision analysis for drug benefit–risk assessment

Author:

Menzies Tom12ORCID,Saint-Hilary Gaelle34ORCID,Mozgunov Pavel5ORCID

Affiliation:

1. Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, UK

2. Department of Mathematics and Statistics, Lancaster University, UK

3. Department of Biostatistics, Institut de Recherches Internationales Servier (IRIS), France

4. Dipartimento di Scienze Matematiche (DISMA) Giuseppe Luigi Lagrange, Politecnico di Torino, Italy

5. MRC Biostatistics Unit, University of Cambridge, UK

Abstract

Multi-criteria decision analysis is a quantitative approach to the drug benefit–risk assessment which allows for consistent comparisons by summarising all benefits and risks in a single score. The multi-criteria decision analysis consists of several components, one of which is the utility (or loss) score function that defines how benefits and risks are aggregated into a single quantity. While a linear utility score is one of the most widely used approach in benefit–risk assessment, it is recognised that it can result in counter-intuitive decisions, for example, recommending a treatment with extremely low benefits or high risks. To overcome this problem, alternative approaches to the scores construction, namely, product, multi-linear and Scale Loss Score models, were suggested. However, to date, the majority of arguments concerning the differences implied by these models are heuristic. In this work, we consider four models to calculate the aggregated utility/loss scores and compared their performance in an extensive simulation study over many different scenarios, and in a case study. It is found that the product and Scale Loss Score models provide more intuitive treatment recommendation decisions in the majority of scenarios compared to the linear and multi-linear models, and are more robust to the correlation in the criteria.

Funder

Medical Research Council

National Institute for Health Research

Publisher

SAGE Publications

Subject

Health Information Management,Statistics and Probability,Epidemiology

Reference26 articles.

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3. FDA. Providing postmarket periodic safety reports in the ICH E2C(R2) format. U.S. Food and Drug Administrationhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-postmarket-periodic-safety-reports-ich-e2cr2-format-periodic-benefit-risk-evaluation?source=govdelivery, journal=U.S. Food and Drug Administration (2013, accessed 30th August 2019).

4. Current Assessment of Risk–Benefit by Regulators: Is It Time to Introduce Decision Analyses?

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