Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?
Date
2010-02ICR Author
Author
Carden, CP
Sarker, D
Postel-Vinay, S
Yap, TA
Attard, G
Banerji, U
Garrett, MD
Thomas, GV
Workman, P
Kaye, SB
de Bono, JS
Type
Journal Article
Metadata
Show full item recordAbstract
Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents.
Subject
Humans
Neoplasms
Antineoplastic Agents
Drug Approval
Pharmacogenetics
Models, Biological
Patient Selection
Clinical Trials, Phase I as Topic
Biomarkers, Pharmacological
Drug Discovery
Research team
Clinical Pharmacology – Adaptive Therapy
Medicine Drug Development Unit (de Bono)
Prostate Cancer Targeted Therapy Group
Cell Cycle Control (including GCLP Biomarker Group)
Medicine Drug Development Unit (Kaye)
Treatment Resistance
Language
eng
Date accepted
2009-11-25
License start date
2010-02
Citation
Drug discovery today, 2010, 15 (3-4), pp. 88 - 97