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
Pashova, Hristina; LeBlanc, Michael; Kooperberg, Charles (2017) Structured detection of interactions with the directed lasso. Stat Biosci 9:676-691
Othus, M; Wood, B L; Stirewalt, D L et al. (2016) Effect of measurable ('minimal') residual disease (MRD) information on prediction of relapse and survival in adult acute myeloid leukemia. Leukemia 30:2080-2083
Walter, R B; Othus, M; Burnett, A K et al. (2015) Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center. Leukemia 29:312-20
Walter, R B; Othus, M; Paietta, E M et al. (2015) Effect of genetic profiling on prediction of therapeutic resistance and survival in adult acute myeloid leukemia. Leukemia 29:2104-7
Walter, Roland B; Othus, Megan; Löwenberg, Bob et al. (2015) Empiric definition of eligibility criteria for clinical trials in relapsed/refractory acute myeloid leukemia: analysis of 1,892 patients from HOVON/SAKK and SWOG. Haematologica 100:e409-11
Kernstine, Kemp H; Moon, James; Kraut, Michael J et al. (2014) Trimodality therapy for superior sulcus non-small cell lung cancer: Southwest Oncology Group-Intergroup Trial S0220. Ann Thorac Surg 98:402-10
Hoering, Antje; Mitchell, Alan; LeBlanc, Michael et al. (2013) Early phase trial design for assessing several dose levels for toxicity and efficacy for targeted agents. Clin Trials 10:422-9
Redman, Mary W; Goldman, Bryan H; LeBlanc, Michael et al. (2013) Modeling the relationship between progression-free survival and overall survival: the phase II/III trial. Clin Cancer Res 19:2646-56
Walter, Roland B; Othus, Megan; Burnett, Alan K et al. (2013) Significance of FAB subclassification of ""acute myeloid leukemia, NOS"" in the 2008 WHO classification: analysis of 5848 newly diagnosed patients. Blood 121:2424-31
Pashova, H; LeBlanc, M; Kooperberg, C (2013) Boosting for detection of gene-environment interactions. Stat Med 32:255-66

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