PROJECT SUMMARY The biostatistics core will support all statistical analyses and design of experiments for the Program project application entitled “Immunologic Approaches to Ovarian Cancer” lead by Dr Spriggs. The role of the biostatistics core is to support the investigators of the Program Project (P01) in Ovarian Cancer in their research efforts, including designing and analyzing in-vivo and in-vitro experiments, tumor biology studies, and clinical trials. In all studies, core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. In the design phase, a core member will collaborate with the investigators in outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, a trial design and a protocol review if necessary, analysis plans, and a targeted sample size justified in probabilistic terms. At the conclusion of the experiment, data analyses will be performed to assess outcomes of the primary and secondary aims as stated in the P01 application. The molecular epidemiology of ovarian cancer will be investigated using array experiments, experiments in cell lines, animals and patients. The specific aims of the biostatistics core are the following: 1) Contribute to the design and analysis of laboratory studies, tumor biology studies, and clinical trials in ovarian cancer research. 2) Assist investigators in assembling study databases, monitoring data quality, and reviewing the adequacy of design assumptions. 3) Prepare reports for the internal and external advisory committees. 4) Write project manuscripts in collaboration with project investigators. 5) Suggest analysis and design strategies for future studies.6) Develop statistical methodology that will assist in the advancement of ovarian cancer research. Dr. Iasonos will be the director of the Biostatistics Core and she will be responsible for the design and analysis of clinical experiments. She will complete this task with the assistance of Ms Zhou who has been working with oncologists, surgeons and pathologists from the Gynecologic service since 2006. Dr. Seshan who is currently the Director of Biostatistics Computer-Intensive Support Services will provide an advisory role since he has been a co-director of the Core for the Ovarian P01 for the past 15 years. Finally, the core will utilize the Biostatistics Service at Memorial Sloan Kettering Cancer Center (MSKCC). The Service consists currently of 35 biostatisticians, 19 of them with professional staff appointments and 16 with masters degrees and research appointments.

PROJECT NARRATIVE The biostatistics core will support all statistical analyses and design of experiment for the Program project application entitled “Immunologic Approaches to Ovarian Cancer” lead by Dr Spriggs. The research will be conducted at three sites: Memorial Sloan-Kettering Cancer Center, Mount Sinai School of Medicine, and Rockefeller University. The role of the biostatistics core is to support all the investigators and leaders of all projects of the Program Project (P01) in Ovarian Cancer in their research efforts. This includes designing and analyzing all pre-clinical experiments, tumor biology studies, and clinical trials. In all studies, core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. In the design phase, a core member will collaborate with the investigators in outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, a trial design and a protocol review if necessary, analysis plans, and a targeted sample size.