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Semin Oncol. 2010 Aug;37(4):359-66. doi: 10.1053/j.seminoncol.2010.06.015.

Phase II cancer prevention clinical trials.

Author information

  • 1Lung and Upper Aerodigestive Cancer Research Group, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. szaboe@mail.nih.gov

Abstract

The development of agents to prevent cancer requires an iterative process of target identification, preclinical testing, and early and late phase clinical trials to establish efficacy and safety. Since phase III definitive efficacy trials with cancer endpoints require a lengthy timeframe and considerable resources for completion, it is critical to first optimize agent delivery and trial design and to determine preliminary efficacy via the conduct of phase II trials. Phase II trials vary considerably in their endpoints, cohorts, and designs due to differences in the process of carcinogenesis and ability to sample tissues across different target organs. However, the goal of all such trials is to provide evidence of interference with the development of cancer and to identify safety signals that would limit the benefit from interventions.

Published by Elsevier Inc.

PMID:
20816506
[PubMed - indexed for MEDLINE]
PMCID:
PMC2935910
Free PMC Article
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