Clinical biomarkers in drug discovery and development
Top Cited Papers
- 1 July 2003
- journal article
- review article
- Published by Springer Nature in Nature Reviews Drug Discovery
- Vol. 2 (7) , 566-580
- https://doi.org/10.1038/nrd1130
Abstract
Biomarkers enable the characterization of patient populations and quantitation of the extent to which new drugs reach intended targets, alter proposed pathophysiological mechanisms and achieve clinical outcomes. In genomics, the biomarker challenge is to identify unique molecular signatures in complex biological mixtures that can be unambiguously correlated to biological events in order to validate novel drug targets and predict drug response. Biomarkers can stratify patient populations or quantify drug benefit in primary prevention or disease-modification studies in poorly served areas such as neurodegeneration and cancer. Clinically useful biomarkers are required to inform regulatory and therapeutic decision making regarding candidate drugs and their indications in order to help bring new medicines to the right patients faster than they are today.Keywords
This publication has 150 references indexed in Scilit:
- A Gene-Expression Signature as a Predictor of Survival in Breast CancerNew England Journal of Medicine, 2002
- Predictive molecular markers in the adjuvant therapy of breast cancer: state of the art in the year 2002International Journal of Clinical Oncology, 2002
- Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implicationsProceedings of the National Academy of Sciences, 2001
- Computational analysis of microarray dataNature Reviews Genetics, 2001
- Biomarkers and surrogate endpoints: Preferred definitions and conceptual frameworkClinical Pharmacology & Therapeutics, 2001
- A gene expression database for the molecular pharmacology of cancerNature Genetics, 2000
- New Guidelines to Evaluate the Response to Treatment in Solid TumorsJNCI Journal of the National Cancer Institute, 2000
- Selective serotonin reuptake inhibitors and neuroendocrine functionLife Sciences, 1999
- Early Lung Cancer Action Project: overall design and findings from baseline screeningThe Lancet, 1999
- Emotion elicitation using filmsCognition and Emotion, 1995