The Biostatistical and Clinical Core will provide the expertise needed to support the laboratory and clinical research of all four SPORE Projects and the Developmental Research and Career Enhancement projects. The Biostatistical and Clinical Core provides critical support regarding experimental design, data capture and management, data analysis, compliance, and reporting. Integration of the biostatistical and clinical research teams represented in this Core ensures well-founded experimental designs at the planning phase, and their ongoing interaction allows for any adjustments in the planned analyses and experiments to be optimized. A single, shared Biostatistical and Clinical Core will improve performance of SPORE-driven projects and clinical trials and will ensure that the work is performed in the most cost-effective and coordinated manner possible. In addition, the leaders of this Core have considerable combined experience in dealing with the specific challenges that arise in designing and conducting clinical studies for brain tumors. This includes knowledge regarding molecular subtype analysis, neuroimaging endpoints, combination therapies, and toxicity assessments. The Biostatistical Co-leader is Annette Molinaro, PhD, who will work with the individual leaders from all four Projects to assess the statistical and database needs of each. She will provide advice on the design of experimental and clinical studies, including the clinical trial in Aim 3 of Project 4; 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 applications of statistical test; and, when appropriate, the development of novel methods to help interpret results from experiments. Under Dr. Molinaro's supervision, the Core has established and will expand and maintain the UCSF Brain Tumor Center Database, which will be the primary, centralized repository for annotated 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, Susan Chang, MD, will interact with all Project leaders in the planning and conduct of the clinical studies and assessment of results. This includes reviewing the prognostic value of the blood immunomethylomics results from the population science studies in Project 1; assess the effect of novel metabolic imaging studies planned in patients in Project 2 as they relate to important clinical endpoints; and to interpret the results of Projects 3 and 4 to determine whether they can be used to reliably stratify patients by specific biological pathways in future clinical trials. Most importantly, Dr. Chang will be instrumental in developing and conducting a planned clinical trial based upon laboratory investigations in Project 4, projected for years 4 and 5 of the grant cycle. The Core will oversee all clinical studies, provide clinical research nurses and data coordinators, and assist in all of the required regulatory and compliance reporting. Working with Dr. Butowski, the clinical co-PI for Project 4, Dr. Chang will facilitate interactions with CTEP, cooperative groups, and biopharmaceutical and industry groups 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; to identify unique stratification factors from human biospecimen analysis for clinical trial implementation; and to activate an early phase clinical trial evaluating toxicity, pharmacokinetics, and pharmacodynamics of a novel agent. The Core will supply statistical and clinical leadership and input towards those efforts as well as the developmental programs.
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