作者: Mark R. Trusheim , Breon Burgess , Sean Xinghua Hu , Theresa Long , Steven D. Averbuch
DOI: 10.1038/NRD3557
关键词:
摘要: Co-developing a drug with diagnostic to create stratified medicine — therapy that is targeted specific patient population on the basis of clinical characteristic such as biomarker predicts treatment response presents challenges for product developers, regulators, payers and physicians. With aim developing shared framework tools addressing these challenges, here we present an analysis using data from case studies in oncology Alzheimer's disease, coupled integrated computational modelling outcomes developer economic value, quantify effects decisions related key issues design trials. This illustrates how analyses can aid coordination development, selection optimal development commercialization strategies. It also impact interplay factors feasibility medicine, which has important implications public policy makers.