ABSTRACT
Concern about insufficient transparency, communicability, and consistency of drug decision making by regulators led four senior European drug regulators1 to write in the New England Journal of Medicine:
CONTENTS
5.1 Introduction .................................................................................................. 59 5.2 How Regulators Assess New Medicinal Products .................................63 5.3 Tools and Methods for Benefit-Risk Assessment ....................................64 5.4 Decision Theory and Social Process .........................................................66 5.5 An Agenda for Multicriteria Decision Analysis ...................................... 69 5.6 An Illustrative Example .............................................................................. 71
5.6.1 Context...............................................................................................72 5.6.2 Alternatives .......................................................................................72 5.6.3 Criteria and Effects Tree .................................................................72 5.6.4 Weighting ..........................................................................................75 5.6.5 Scoring and Value Functions ......................................................... 79 5.6.6 Results ...............................................................................................83 5.6.7 Sensitivity Analyses ........................................................................84 5.6.8 Scenario Analysis ............................................................................. 87
5.7 Discussion .....................................................................................................88 5.7.1 The Double-Counting Bias and Its Correction ............................ 89 5.7.2 Why the Resistance? ........................................................................ 91
5.8 Conclusions ................................................................................................... 93 References ............................................................................................................... 94
Exploration of explicit quantitative approaches began to appear two decades earlier: Ciba-Geigy sponsored a 2-day workshop at the London School of Economics in 1989, followed by another workshop in 1990 sponsored by the Centre for Medicines Research (CMR), both of which brought together drug regulators with managers from the pharmaceutical industry to explore how quantitative modeling might assist drug decision makers.2 Although quantitative models developed on the spot in both seminars demonstrated the potential for combining different types and sources of data with clinical judgment, it was clear that improving and making explicit decisions about drugs were not widely considered to be serious concerns.
