Biostatistics, Outcomes Modeling, Clinical Design, and Administration

该核心的总体目标是提供行政支持、项目间沟通、总体 科学领导，为所有项目和核心提供核心科学服务，以确保科学目标 实现了计划项目的实现。核心职能1是提供生物统计和数据管理支持 所有的项目和核心。由核心支持的生物统计师将对详细研究做出贡献 所有项目的设计和假设检验，并将支持专业生物数学的需求 项目1-4，如随机估计和解剖抽样。核心功能2是开发 IGART计划评价和VIRTUAL结果评分的生物有效剂量和理论结果模型 临床试验。核心领导者将与该计划的生物建模顾问合作，选择最 适当的生物有效剂量、肿瘤控制和正常组织反应模型，并确定适当的 可从中提取此类参数的模型参数和/或已发表的结果研究。这个 项目生物统计师将为模型拟合过程提供指导和支持。这些模型将是 由项目2-4和核心A使用来评估治疗计划，指导优化，制定临床 假设，对虚拟临床试验进行评分，并对不同剂量-时间-分割的剂量分布进行汇总 模式。核心职能3将负责为所有主要的科学研究提供临床指导 这项计划的发展。一个积极的临床开发工作组，由所有临床联合 调查人员将与项目和核心领导一起参与图像指导的制定 影像引导自适应放射治疗的程序、虚拟临床试验和候选过程 (IGART)。该核心功能的主要任务是使用经过临床测试的IGART设计内部临床试验 技术来实施某种形式的剂量递增。此外，Core Function 3还将提供临床数据 为管理人类受试者对项目3和4临床研究的应计费用提供管理支持 并确保遵守VCU IRB和有关保护人类受试者的联邦法规。 核心职能4是提供行政支助，促进项目间科学交流，以及 为所有项目和核心提供全面的科学指导。行政支持的主要领域 包括人事和预算管理、采购和手稿准备以及秘书/文书 支持。核心还将提供一个集中的通信矩阵，包括与 NCI/NIH，不同项目和核心之间的连接和科学交流，以及一体化 外部咨询委员会对PPG研究计划执行情况的反馈。这将会实现的 通过规定的每周项目/核心会议、所有调查人员每月会议和年度面对面会议 与外部咨询委员会董事会一起进行实地考察。

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.