Topics in Statistical Theory and Methods for Cancer Clinical Trials

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Cancer is a major public health problem in Canada and around the world. Research on the cause, detection, prevention and treatment of cancer is one of the most active research areas in the health sciences. Clinical trials are key component in the development of new drugs or procedures to treat the cancer or prevent the development of the cancer. Statistical methods play a pivotal role in the design and analysis of cancer clinical trials. Because of rapid progress in the understanding of cancer biology, many new drugs and treatment procedures have been developed in the recent years. New statistical methods are required to make the clinical trials evaluating these drugs and procedures more accurate and efficient.***Development and evaluation of these new statistical methods with applications to the clinical trials conducted by the NCIC Clinical Trials Group has been the primary topic of our research program. We plan to continue this research program with focus on the study of the following four problems we have encountered recently in our practices: ***(1) Statistical inference of two-stage phase II cancer clinical trials with correlated endpoints; ***(2) Statistical inference procedures for an alternative measure of treatment effect based on paired survival data; ***(3) Statistical procedures for the analysis of survival outcomes from covariate-adaptive designs; ***(4) Statistical methods for the identification of predictive signatures from multiple and correlated biomarkers.***It is expected that this research will generate some new statistical tools for applied statisticians working in clinical trials and other related areas and also lay solid mathematical foundations for these new methods, which will result in more efficient and reliable identification of new strategies for the prevention and treatment of cancer and, therefore, reduction of morbidity and mortality from cancer. It is also expected this research will stimulate new development in the mathematical theory of probability and statistics. The theory and methods developed from this project may be applied to the evaluation of treatment for other diseases and also other fields of natural science and engineering. All levels of Highly Qualified Personnel will be trained through the participation in the projects listed in this proposal. **