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. Clinical trial is a key component in the development of new drug or procedure 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 statistical methods with applications to the clinical trials has been primary topic of our research program. We plan to continue this research program with focus on the study of the following new problems encountered recently in our practices: (1) Statistical analysis for paired survival data with applications to design and analysis of phase II cancer clinical trial; (2) Statistical procedure for evaluating effect of cancer biomarkers: (3) Variable selection in high-dimensional models in survival analysis; and (4) Joint modeling of longitudinal quality of life and survival data. It is expected that this research will generate some new methods for applied statisticians working in clinical trials with time-to-event endpoints and lay solid mathematical foundations for these methods, which will result in more efficient and reliable identification of new strategies for the prevention and treatment of the cancer and, therefore, reduction of morbidity and mortality from cancer. Methods developed from this research have also potential applications to clinical trials of other types of diseases, such as HIV AIDs and cardiovascular diseases, and also to some other types of medical researches, such as cohort designs in epidemiological studies. They may also be applied to other areas of science and engineering, such as psychology and reliability engineering. The proposed research will also provide excellent opportunities to train next generation of researchers working in advancing statistical theory and methodology and also knowledge in our understanding and treatment of diseases.