ADVANCED TECHNOLOGY QA CENTER

先进技术质量保证中心

• 批准号: 6554884
• 负责人: JAMES A PURDY
• 金额: $ 159.04万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-22 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6554884
• 关键词: Internet; cancer complication; cancer information system; cancer registry /resource; clinical research; clinical trials; computer program /software; computer system design /evaluation; cooperative study; data collection methodology /evaluation; disease /disorder model; experimental designs; health care quality; hemorrhage; human data; model design /development; neoplasm /cancer radiation therapy; neoplasm /cancer radionuclide therapy; patient care management; patient care planning; statistics /biometry; technology /technique development

DESCRIPTION (provided by applicant): Our goal remains the same as put forth in our original proposal, i.e., to capitalize on the infrastructure and strengths of the existing national quality assurance (QA) programs, including the Image-Guided Therapy Center (ITC) (previously referred to as the 3DQA Center in the original grant), Quality Assurance Review Center (QARC), Radiological Physics Center (RPC), and the, Radiation Therapy Oncology Group(RTOG) to create an Advanced Technology Radiation Therapy Clinical Trials Support (ATC) QA consortium. Our ATC QA consortium approach will avoid duplication of these already defined programs, while strengthening interactions between QA groups which promote the development of common QA for advanced technology clinical trials throughout all participating Cooperative Groups. Specifically, we will (1) provide and/or facilitate QA review of RTOG clinical trials that utilize advanced technologies including, but not limited to, three-dimensional radiation therapy treatment planning and delivery(3DCRT), intensity modulated radiation therapy (IMRT), stereotactic radiosurgery/radiation therapy, and brachytherapy;(2)assist(facilitate receipt of digital data) QARC in their QA review of cooperative group clinical trials that utilize advanced technologies;(3) assist (facilitate receipt of digital data) RPC in their QA review of cooperative group clinical trials that utilize advanced technologies; (4) develop Monte Carlo simulation capability (through a subcontract with Fox Chase Cancer Center) for the purpose of credentialing and QA pertaining to clinical trials utilizing advanced technologies;(5) develop QA and credentialing criteria that is compatible with the level of complexity of the clinical trial treatment regimens;(6) create mechanisms and software tools to facilitate QA reviews of treatment planning and verification(TPV) data submitted by institutions participating in cooperative group clinical trials (both pediatric and adult) that utilize advanced technologies. Emphasis will be on the development and improvement of web-based remote-review tools that allow for the efficient review of centrally-located image-based data by reviewers not co-located with the data; (7) develop efficient methodologies for electronic data exchange of TPV data between the ITC and the participating institutions, remotely located QA review group(s), and Cooperative Group?s Operations, Statistics, and Data Management Group(s); (8) develop and maintain an archival TPV database that can be linked with the Cooperative Group?s clinical outcomes database; (9) construct normal tissue complication probability(NTCP) models to demonstrate use of TPV database, and (10) serve as a resource to the nation?s Cooperative Groups and participating institutions for support of advanced technology radiation therapy dinical trials.

描述（由申请人提供）： 我们的目标与我们最初的提议中提出的相同，即 利用现有国家的基础设施和优势 质量保证（QA）计划，包括图像指导的治疗中心 （ITC）（以前称为原始赠款中的3DQA中心）， 质量保证审查中心（QARC），放射物理中心（RPC）和 放射疗法肿瘤学小组（RTOG）创建高级技术 放射治疗临床试验支持（ATC）质量检查联盟。我们的ATC QA 财团方法将避免重复这些已经定义的程序， 同时加强质量检查组之间的相互作用，以促进 开发整个高级技术临床试验的常见质量检查 所有参与的合作团体。具体而言，我们将（1）提供和/或 促进使用高级的RTOG临床试验的质量检查 技术包括但不限于三维辐射 治疗治疗计划和分娩（3DCRT），强度调节辐射 治疗（IMRT），立体射线外科/放射治疗和 近距离放射治疗；（2）协助（促进收到数字数据）QARC的质量检查 利用高级的合作团体临床试验的审查 技术；（3）协助（促进收到数字数据）RPC在其质量上 利用高级的合作团体临床试验的审查 技术； （4）发展蒙特卡洛模拟能力（通过 与Fox Chase Cancer Center的分包合同）是为了证书和 使用先进技术与临床试验有关的质量请QA；（5）发展 与复杂程度兼容的QA和凭证标准 （6）创建机制和软件工具来促进质量检查计划和验证（TPV） 由参加合作集团临床的机构提交的数据 利用高级技术的试验（小儿和成人）。强调 将在基于Web的遥控工具的开发和改进方面 这可以通过 评论者未与数据共同分享； （7）开发有效的方法论 用于电子数据交换ITC和参与之间的TPV数据 机构，位于QA审查小组和合作集团的机构 操作，统计和数据管理小组； （8）发展和维护 可以将合作组链接的档案TPV数据库 临床结果数据库； （9）构建正常组织并发症 证明使用TPV数据库的概率（NTCP）模型，（10）用作 国家合作团体和参与机构的资源 为了支持先进的技术放射疗法DINICAL试验。