A quantitative approach to benefit-risk assessment of medicines – part 1: the development of a new model using multi-criteria decision analysis

Abstract

This novel approach based on MCDA has the potential for being applied as a new tool for judging and deciding on the benefits and risks, thereby helping regulators and industry in the development and approval of new medicines and their adequate use.

A first step to assess harm and benefit in clinical trials in one scale

“…This statement was repeated by a committee of the Committee for Medicinal Products for Human Use of the European Medicines Agency in 2007 [2] and expanded by Mussen et al [3]. One of the problems is that benefit and risk assessment is mostly driven by the need to make decisions, whereas most research is ''truth driven.''…”

A Unified Framework for Classification of Methods for Benefit-Risk Assessment

“…MCDA can be used to organize different elements of a complex decision, provide a systematic and transparent assessment of the problem, and document the thought process leading to a decision in a tractable format [20]. The first step of an MCDA is to establish the decision context that involves identifying key decision makers, defining the treatment options of interest, and discussing the aims and context of the problem.…”

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

“…The debut of MCDA for the BR assessment of new drugs was provided by Mussen et al [5]. The principle of the method is to compare drugs using utility scores calculated from multiple criteria of benefits and risks, taking into account their relative importance according to the preferences (a.k.a.…”