Biostatistics, Outcomes Modeling, Clinical Design, and Administration

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The overall goal of this Core is to provide administrative support, interproject communications, overall scientific leadership, and Core scientific services to all Projects and Cores to ensure that the scientific aims of Program Project are realized. Core Function 1 is to provide biostatistical and data management support to all Projects and Cores. The faculty biostatistician supported by the Core will contribute to detailed study design and hypothesis testing for all Projects and will support the specialized biomathematics needs of Projects 1-4 such as stochastic estimation and anatomy sampling. Core Function 2 is to develop bioeffective dose and theoretical outcome models for IGART plan evaluation and scoring outcomes of virtual clinical trials. The Core Leader will work with the Program's biomodelling consultant to select the most appropriate bioeffective dose, tumor control, and normal tissue response models and to identify appropriate model parameters and/or published outcome studies from which such parameters can be extracted. The Program biostatistician will provide guidance and support for model fitting procedures. These models will be used by Projects 2-4 and Core A to evaluate treatment plans, guide optimization, formulate clinical hypotheses, score virtual clinical trials, and to sum dose distributions with differing dose-time-fractionation patterns. Core Function 3 will be responsible for providing clinical guidance to all major scientific developments of this Program. An active Clinical Development Working Group, consisting of all clinical co- investigators along with Project and Core Leaders, will participate in the formulation of image guidance procedures, virtual clinical trials, and candidate processes for image-guided adaptive radiation therapy (IGART). A major task of this Core Function is to design intramural clinical trials using clinically-tested IGART technology to implement some form of dose escalation. In addition, Core Function 3 will provide clinical data management support for managing the accrual of human subjects to the Projects 3 and 4 clinical studies and to assure compliance with VCU IRB and federal regulations regarding the protection of human subjects. Core Function 4 is to provide administrative support, to promote inter-Project scientific communication, and to provide overall scientific direction to all Projects and Cores. The primary areas of administrative support include personnel and budget management, purchasing and manuscript preparation, and secretarial/clerical support. The Core will also provide a centralized communication matrix, including communication with NCI/NIH, connectivity and scientific communication among the different Projects and Cores, and integration of the External Advisory Board feedback into the PPG research plan execution. This will be achieved through required weekly Project/Core meetings, monthly meetings of all investigators, and annual face-to- face site visits with the External Advisory Committee Board.