Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
@article{Atkinson2001BiomarkersAS, title={Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework}, author={A. Atkinson and W. Colburn and V. DeGruttola and D. Demets and G. Downing and D. Hoth and J. Oates and C. Peck and R. Schooley and B. Spilker and J. Woodcock and S. Zeger}, journal={Clinical Pharmacology & Therapeutics}, year={2001}, volume={69} }
genome are dramatically reshaping the research and development pathways for drugs, vaccines, and diagnostics. The growth in the number of molecular entities entering the drug development pipeline has accelerated as a consequence of powerful discovery and screening technologies such as combinatorial chemistry, mass spectrometry, high throughput screening, celland tissue-based DNA microarrays, and proteomic approaches.1 As a consequence, there is an escalating number of therapeutic candidates… CONTINUE READING
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References
SHOWING 1-10 OF 32 REFERENCES
Meta-analysis for the evaluation of potential surrogate markers.
- Medicine
- Statistics in medicine
- 1997
- 289
New molecular endpoints and methods for routine toxicity testing.
- Biology, Medicine
- Fundamental and applied toxicology : official journal of the Society of Toxicology
- 1995
- 40
Importance of surrogate markers in evaluation of antiviral therapy for HIV infection.
- Medicine
- JAMA
- 1996
- 27
Surrogate End Points in Clinical Trials: Are We Being Misled?
- Medicine
- Annals of Internal Medicine
- 1996
- 1,401
- PDF
Surrogate endpoints in clinical trials: definition and operational criteria.
- Medicine
- Statistics in medicine
- 1989
- 1,621
DNA Damage as an Intermediate Biomarker in Intervention Studies
- Chemistry, Medicine
- Proceedings of the Society for Experimental Biology and Medicine. Society for Experimental Biology and Medicine
- 1997
- 37
Surrogate end points, health outcomes, and the drug-approval process for the treatment of risk factors for cardiovascular disease.
- Medicine
- JAMA
- 1999
- 183
- PDF
Evaluating surrogate markers.
- Medicine
- Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association
- 1995
- 31
Statistical validation of intermediate endpoints for chronic diseases.
- Medicine
- Statistics in medicine
- 1992
- 558