Journal
JOURNAL OF STATISTICAL PLANNING AND INFERENCE
Volume 138, Issue 2, Pages 308-320Publisher
ELSEVIER
DOI: 10.1016/j.jspi.2007.06.010
Keywords
pharmacogenomics; biomarker; genomics; DNA microarray; clinical trial design validation
Categories
Funding
- Intramural NIH HHS [Z99 CA999999] Funding Source: Medline
Ask authors/readers for more resources
Many syndromes traditionally viewed as individual diseases are heteroaeneous in molecular pathogenesis and treatment responsiveness. This often leads to the conduct of large clinical trials to identify small average treatment benefits for heterogeneous groups of patients. Drugs that demonstrate effectiveness in such trials may subsequently he used broadly, resulting in ineffective treatment of many patients. New genomic and proteornic technologies provide powerful tools for the selection of patients likely to benefit from a therapeutic without unacceptable adverse events. In spite of the large literature on developing predictive biomarkers, there is considerable confusion about the development and validation of biomarker-based diagnostic classifiers for treatment selection. In this paper we attempt to clarify some of these issues and to provide guidance on the design of clinical trials for evaluating the clinical utility and robustness of pharmacogenomic classifiers. Published by Elsevier B.V.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available