TAS::75 0850::TAS RECOVERY ACT ADOPT COMMON INFRASTRUCTURE SUPPORT UNDER OPERATI

塔斯马尼亚州::75 0850::塔斯马尼亚州恢复法案在运营中采用通用基础设施支持

• 批准号: 7976318
• 负责人: SUDHIR RAJU
• 金额: $ 51.48万
• 依托单位: CTIS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7976318
• 关键词: TAS; 75; 0850; RECOVERY; ACT

Recovery money was added to the Cancer Therapy Evaluation Program's Informatics and Computer Support contract in support of the program, "ADOPTion of New Technologies for Remote Data Capture & Protocol Authoring (ADOPT) " Recent independent analyses of the National Cancer Institute¿s (NCI) clinical trials systems have indicated an urgent need to re-evaluate engrained processes and to find novel solutions if investigators are to take full advantage of scientific opportunities available today for clinical research. The Division of Cancer Treatment and Diagnosis (DCTD), primarily through its Cancer Therapy Evaluation Program (CTEP), sponsors several multi-institution clinical trial organizations, NCI Cooperative Groups and Consortia, that conduct both early phase and late phase multi-institutional trials that evaluate anticancer therapies designed to improve multiple outcomes including symptom-control, quality of life and overall survival. The Groups and consortia encompass many of the nation¿s leading NCI-designated Comprehensive Cancer Centers, academic centers in adult and pediatric oncology (with participating sites in every state), and specialized Oncology Consortia devoted to the study of brain and childhood cancers. The Groups receive operational, technical, and regulatory support from the Cancer Trials Support Unit In order to rapidly bridge the gap between the expanding array of pre-clinical opportunities and the existing approaches to patient care increased attention must be devoted to the numerous processes underlying clinical trial development. Significant groundwork has been laid to reconfigure the NCI trials infrastructure. In order for these initiatives to achieve their full potential, NCI and the extramural clinical investigator community must now direct their attention and energies to improving the process by which clinical trials are developed and conducted if we are to realize the goal of more rapid progress against cancer. In keeping with both the numerous stakeholders involved and the complexities of the various processes, the NCI is proposing a multi-pronged approach to address the barriers that must be overcome if clinical trials are to provide our patients the answers they so desperately need. These initiatives include the integration of standardized information-technology (IT) tools or operational processes for: ¿ electronic Protocol Authoring (ePA) ¿ electronic Case Report Forms (eCRF) ¿ including: o Oncology Patient Enrollment Network (OPEN) o Common Terminology Criteria for Adverse Events (CTCAE) ¿ Clinical Data Management System (CDMS) Standardization and common infrastructure will improve the efficiency and effectiveness of the CTEP multi-center clinical trial networks while simultaneously providing an opportunity to reduce clinical trial costs. The goal of this overall initiative is to integrate ePA, eCRF and CDMS, into the IT systems and business practices of CTEP, CTSU, Groups and Consortia. In addition the NCI Comprehensive Cancer Centers are participating on the CDMS sub-task. The Cancer Therapy Evaluation Program's Enterprise System (CTEP ESYS) is made up of 22 modules At the present time these modules include but are not limited to: Clinical Trials Monitoring Branch Audit Information System (CTMB-AIS), Protocol Authorization and Tracking System (PATS), Drug Authorization and Review Tracking System (DARTS), Clinical Data Update System (CDUS), Web Enabled CDUS, Common Toxicity Criteria Interactive Tool (CTCAE), Adverse Drug Experience Electronic Reporting Systems (AdEERS), Enterprise Query Wizard (EQW), Financial Instrument and Accrual Tracking System (FIATS), CTEP Account Management System (AMS), Clinical Investigations Branch Information System and Clinical IT (CIBISCIT), Regulatory Affairs Branch Information Tracking System (RABITS), Document Management, Assembly, Review and Tracking System (Docu-MART), and the CTEP Web Page. The primary objectives of the CTEP Enterprise System are to: ¿ Capture data and translate it into a usable format to address the scientific, safety, regulatory and administrative needs of CTEP and the NCI. ¿ Eliminate data redundancy throughout the oncology community ¿ Streamline clinical research operations. ¿ Reduce the administrative burden on NCI staff, contractors, and extramural researchers. ¿ Improve communication between CTEP and its collaborators. ¿ Assure the security and confidentiality of proprietary and patient information. ¿ Increase access to clinical trials to all investigators ¿ Capitalize on XML and other technologies to maximize reusability and integration with other systems in the oncology community. ¿ Support broad patient access to clinical trials. ¿ Expedite the protocol development and review process within both clinical trial organizations and reviewing bodies.

恢复资金被添加到癌症治疗评估计划的信息学和计算机支持合同中，以支持该计划，“采用新技术进行远程数据采集和协议编写（ADOPT）“国家癌症研究所最近的独立分析？美国国家癌症研究所（NCI）的临床试验系统表明，迫切需要重新，如果研究人员要充分利用当今临床研究的科学机会，就必须评估根深蒂固的过程并找到新的解决方案。癌症治疗和诊断部（DCTD）主要通过其癌症治疗评估计划（CTEP）赞助了几个多机构临床试验组织，NCI合作组和联盟，这些组织进行早期和晚期多机构试验，评估旨在改善多种结局的抗癌治疗，包括肿瘤控制，生活质量和总生存期。这些团体和联盟包括许多全国领先的NCI指定的综合癌症中心，成人和儿科肿瘤学学术中心（每个州都有参与站点），以及专门研究脑和儿童癌症的专业肿瘤学联盟。这些小组从癌症试验支持部门获得运营、技术和监管支持。为了迅速弥合不断扩大的临床前机会与现有患者护理方法之间的差距，必须更加关注临床试验开发的众多过程。 已经为重新配置国家刑事调查局的审判基础设施奠定了重要基础。为了使这些举措充分发挥其潜力，NCI和校外临床研究者社区现在必须将注意力和精力集中在改善临床试验开发和进行的过程上，如果我们要实现更快地对抗癌症的目标。为了与涉及的众多利益相关者和各种过程的复杂性保持一致，NCI提出了一种多管齐下的方法来解决临床试验必须克服的障碍，以便为我们的患者提供他们迫切需要的答案。这些举措包括整合标准化的信息技术工具或业务流程，以便： 电子方案编写（ePA） 电子病例报告表（eCRF）包括： 肿瘤患者登记网络（OPEN） 不良事件通用术语标准（CTCAE） 临床数据管理系统（CDMS） 标准化和通用基础设施将提高CTEP多中心临床试验网络的效率和有效性，同时提供降低临床试验成本的机会。该总体计划的目标是将ePA、eCRF和CDMS整合到CTEP、CTSU、集团和联盟的IT系统和业务实践中。此外，NCI综合癌症中心正在参与CDMS子任务。 癌症治疗评估计划的企业系统（CTEP ESYS）由22个模块组成，目前这些模块包括但不限于：临床试验监查分支稽查信息系统（CTMB-AIS）、方案授权和跟踪系统（PATS）、药物授权和审查跟踪系统（DARTS）、临床数据更新系统（CDUS）、网络启用CDUS，通用毒性标准交互工具（CTCAE）、药物不良反应电子报告系统（AdEERS）、企业查询向导（EQW）、金融工具和应计跟踪系统（FIATS）、CTEP账户管理系统（AMS）、临床研究分支信息系统和临床IT（CIBISCIT）、法规事务分支信息跟踪系统（RABITS）、文件管理、组装、审查和跟踪系统（Docu-MART）和CTEP网页。CTEP企业系统的主要目标是：捕获数据并将其转换为可用的格式，以满足CTEP和NCI的科学，安全，监管和管理需求。<$消除整个肿瘤学界的数据冗余<$简化临床研究操作。减少NCI工作人员，承包商和校外研究人员的行政负担。改善CTEP及其合作者之间的沟通。确保专有信息和患者信息的安全性和机密性。<$增加所有研究者对临床试验的访问<$利用XML和其他技术，最大限度地提高可重用性，并与肿瘤学界的其他系统集成。支持广泛的患者进入临床试验。加快临床试验组织和审查机构内的方案制定和审查过程。