The identification and evaluation of interventions to reduce mortality and incidence of cancer is of critical public interest. Practical tools for addressing some new and continuing challenges in the design and analysis of clinical studies will be developed. A major emphasis will be placed on the design for Phase 1-111 clinical trials. The new developments will include strategies for early clinical studies of new biologic agents, designs for single arm survival studies, and solutions to several previously unresolved Phase III design issues. Flexible statistical design software will also be developed. New statistical methods for the joint analysis of longitudinal and time to event data in the context of Phase III studies will be investigated. The methods will take a Bayesian approach and utilize Markov Chain Monte Carlo (MCMC) sampling algorithms. There will be development and evaluation of exploratory survival analysis methods. New algorithms for constructing and interpreting prognostic subgroups of patients will be considered. Methodologies for model selection and for combining covariates in clinical association studies of moderate dimensions will also be investigated. Other topics proposed arise directly from our collaborative work on clinical trials. They will include analysis for time within a positive disease state and methods for non-parametric covariate adjustment. Collectively, the project will contribute to improvements in evaluating efficacy of cancer therapies though better methods for design, conduct and analysis of clinical studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA090998-03
Application #
6634038
Study Section
Special Emphasis Panel (ZRG1-SNEM-5 (01))
Program Officer
Erickson, Burdette (BUD) W
Project Start
2001-03-01
Project End
2006-02-28
Budget Start
2003-03-01
Budget End
2004-02-29
Support Year
3
Fiscal Year
2003
Total Cost
$233,550
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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