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Strategies for phase II cancer chemoprevention trials: Cervix, endometrium, and ovary

✍ Scribed by Dr. Gary J. Kelloff; Charles W. Boone; James A. Crowell; Susan G. Nayfield; Ernest Hawk; Vernon E. Steele; Ronald A. Lubet; Caroline C. Sigman

Publisher: John Wiley and Sons
Year: 1995
Tongue: English
Weight: 782 KB
Volume: 59
Category: Article
ISSN: 0730-2312
DOI: 10.1002/jcb.240590902

No coin nor oath required. For personal study only.

✦ Synopsis

Well-designed and conducted Phase 11 clinical trials are very important to cancer chemoprevention drug development. Three critical aspects govern the design and conduct of these trials-wellcharacterized agents, suitable cohorts, and reliable biomarkers for measuring efficacy that can serve as surrogate endpoints for cancer incidence.

Requirements for the agent are experimental or epidemiological data showing chemopreventive efficacy, safety on chronic administration, and a mechanistic rationale for the chemopreventive activity observed. Agents that meet these criteria for chemoprevention of cervical cancer include antiproliferative

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