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- Title
Quantifying factors for the success of stratified medicine.
- Authors
Trusheim, Mark R.; Burgess, Breon; Hu, Sean Xinghua; Long, Theresa; Averbuch, Steven D.; Flynn, Aiden A.; Lieftucht, Alfons; Mazumder, Abhijit; Milloy, Judy; Shaw, Peter M.; Swank, David; Wang, Jian; Berndt, Ernst R.; Goodsaid, Federico; Palmer, Michael C.
- Abstract
Co-developing a drug with a diagnostic to create a stratified medicine - a therapy that is targeted to a specific patient population on the basis of a clinical characteristic such as a biomarker that predicts treatment response - presents challenges for product developers, regulators, payers and physicians. With the aim of developing a shared framework and tools for addressing these challenges, here we present an analysis using data from case studies in oncology and Alzheimer's disease, coupled with integrated computational modelling of clinical outcomes and developer economic value, to quantify the effects of decisions related to key issues such as the design of clinical trials. This illustrates how such analyses can aid the coordination of diagnostic and drug development, and the selection of optimal development and commercialization strategies. It also illustrates the impact of the interplay of these factors on the economic feasibility of stratified medicine, which has important implications for public policy makers.
- Subjects
DRUG development; BIOMARKERS; CLINICAL trials; DRUG analysis; PHARMACODYNAMICS
- Publication
Nature Reviews Drug Discovery, 2011, Vol 10, Issue 11, p817
- ISSN
1474-1776
- Publication type
journal article
- DOI
10.1038/nrd3557