Biostatistics, Outcomes Modeling, Clinical Design, and Administration

生物统计学、结果建模、临床设计和管理

• 批准号: 7214976
• 负责人: JEFFREY F WILLIAMSON
• 金额: $ 24.29万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7214976
• 关键词: Accounting; Advisory Committees; Algorithms; Anatomy; Area; Back; Binomial Distribution; Biometry; Bladder; Blood Vessels; Brachytherapy; Budgets; Cancer Patient; Caring; Cell Survival; Cervical; Cervix Uteri; Chi-Square Distribution; Class; Classification; Clinical; Clinical Data; Clinical Research; Clinical Trials; Commit; Communication; Complex; Complication; Confidence Intervals; Daily; Data; Data Analyses; Data Set; Development; Diagnostic; Dimensions; Disorder by Site; Dose; Drug Formulations; Elements; End Point; Ensure; Evaluation; Experimental Designs; Face; Facility Construction Funding Category; Faculty; Failure; Feedback; Figs - dietary; Fractionation; GDF15 gene; Genetic; Goals; Hemorrhage; Human Resources; Image; Imaging Phantoms; In Vitro; Individual; Intensity-Modulated Radiotherapy; Kolmogorov-Smirnov Test; Label; Leadership; Literature; Location; Lung; Malignant neoplasm of cervix uteri; Malignant neoplasm of lung; Malignant neoplasm of prostate; Manuscripts; Maps; Measurement; Measures; Medical; Medical Imaging; Methodology; Methods; Modality; Modeling; Molecular; Nitrogen; Nodal; Noise; Non-Small-Cell Lung Carcinoma; None or Not Applicable; Normal Statistical Distribution; Normal tissue morphology; Numbers; Operative Surgical Procedures; Organ; Outcome; Outcome Study; PLAB Protein; Patients; Pattern; Pelvis; Performance; Physicians; Physics; Pneumonia; Population; Positioning Attribute; Preparation; Principal Component Analysis; Probability; Procedures; Process; Program Development; Property; Prostate; Publishing; Radiation Oncology; Radiation therapy; Radiobiology; Range; Rate; Recipe; Recording of previous events; Rectum; Regulation; Relative (related person); Research; Research Design; Research Ethics Committees; Research Personnel; Residual state; Risk; Sample Size; Sampling; Scanning; Score; Series; Services; Side; Significance Level; Simulate; Site Visit; Source; Staging; Standards of Weights and Measures; Statistical Methods; Statistically Significant; Structure; Sum; Techniques; Technology; Teflon; Testing; Time; Toxic effect; Uncertainty; Upper arm; Validation; Value Meaning; Variant; Week; Work; base; biomathematics; cancer therapy; clinical efficacy; clinically significant; data management; day; design; desire; experience; fly; human subject; image processing; image registration; improved; indexing; interest; lymph nodes; neglect; prescription document; prescription procedure; programs; reconstruction; rectal; research study; response; simulation; size; time use; treatment planning; tumor; vector; vector control; virtual

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.

该核心的总体目标是提供行政支持，室内通信，总体 科学领导和对所有项目和核心的核心科学服务，以确保科学目标 实现了计划项目的内容。核心功能1是提供生物统计学和数据管理支持 所有项目和核心。由核心支持的教师生物统计学家将有助于详细研究 对所有项目的设计和假设测试，并将支持专门的生物学需求 项目1-4，例如随机估计和解剖学采样。核心功能2是开发 IGART计划评估的生物效率剂量和理论结果模型 临床试验。核心负责人将与该计划的生物模型顾问一起选择最多 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 模型参数和/或已发表的结果研究，可以从中提取此类参数。这 计划生物统计学家将为模型拟合程序提供指导和支持。这些模型将是 项目2-4和核心A使用用于评估治疗计划，指导优化，制定临床 假设，评分虚拟临床试验和与剂量时间不同的剂量分布总和 模式。核心功能3将负责为所有主要科学提供临床指导 该计划的发展。一个主动临床发展工作组，由所有临床共同 调查人员以及项目和核心领导者将参与图像指导的制定 图像引导的自适应放射疗法的程序，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设计壁内临床试验 实施某种剂量升级的技术。此外，核心功能3将提供临床数据 管理支持项目3和4临床研究的人类受试者应计的支持 并确保遵守VCU IRB和有关保护人类受试者的法规。 核心功能4是提供行政支持，促进项目间科学交流以及 为所有项目和核心提供总体科学方向。行政支持的主要领域 包括人员和预算管理，购买和手稿准备以及秘书/文书 支持。核心还将提供集中的通信矩阵，包括与 NCI/NIH，不同项目和核心之间的连通性和科学沟通以及整合 外部咨询委员会对PPG研究计划执行的反馈。这将被实现 通过所需的每周项目/核心会议，所有调查人员的每月会议以及年度面对面 与外部咨询委员会委员会的面对面访问。