Core 2: Biostatistical and Clinical Core

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Project Summary/Abstract The Biostatistical and Clinical Core will provide the expertise need to support the research of all three SPORE Projects and the Developmental Research and Career Enhancement projects. Integration of the biostatistical and clinical research teams in this Core ensures well-founded experimental designs in the planning phase and allows for adjustments in planned analyses and experiments. A single shared Core will improve the performance of SPORE-driven projects and clinical trials and ensure that the work is coordinated and cost-effective. The Core leaders have considerable combined experience managing challenges arising in the design and conduct of clinical studies for brain tumors including knowledge of molecular subtypes, neuroimaging endpoints, on- treatment tumor tissue collection and analysis, and toxicity assessments. The Biostatistics Co-leader is Annette Molinaro, Ph.D., will work with individual leaders from all three Projects to assess the statistical and database needs. She will provide advice on the design of experimental and clinical studies, including the clinical trial in Aim 1 of Project 3; data analysis guidance (either by performing the analyses within the core or advising qualified personnel within the projects), including the use of appropriate statistical models and appropriate applications of statistical tests; and the development of novel methods to help interpret results from experiments. Under Dr. Molinaro’s supervision, the Core built and will continue to expand and maintain the UCSF Brain Tumor Center Database (BTCDB). The BTCDB will be the primary, centralized repository for annotated research and clinical data used by all SPORE investigators. This unique and customizable resource will connect clinical information to imaging, tissue, and genomic parameters generated by the SPORE projects. The Clinical Co-leader, John de Groot, M.D., will interact with all Project leaders in planning and conducting clinical studies and assessing results including review of the prognostic value of blood immunomethylomics from the population science studies in Project 1 and evaluating the effect of novel metabolic imaging studies in patients in Project 2. Importantly, Dr. de Groot will be instrumental in developing and conducting a planned clinical trial in Project 3. The Core will oversee all clinical studies, provide clinical research nurses and data coordinators, and assist in the required regulatory and compliance reporting. Working with Dr. Clarke, the clinical co-PI for Project 3, Dr. de Groot will facilitate interactions with the Hematology, Blood and Marrow Transplantation, and Cellular Therapy program (HBC) and Living Therapeutics Initiative Program at UCSF, NCI, and FDA, to efficiently activate and conduct the clinical trial. The primary objective of this Core is to support the translational research of the Projects that are designed to identify robust prognostic markers; to develop non-invasive imaging techniques that inform more accurately on early response to therapy and tumor burden; and to activate an early phase clinical trial evaluating toxicity, pharmacokinetics, and pharmacodynamics of a novel cell therapy. The Core will supply statistical and clinical leadership and input towards those efforts and the developmental programs.