TAS::75 0850::TAS RECOVERY ACT ACTNOW CLINICAL TRIAL SUPPORT - CTEP IT Support

TAS::75 0850::TAS 恢复法案 ACTNOW 临床试验支持 - CTEP IT 支持

• 批准号: 8534635
• 负责人: SUDHIR RAJU
• 金额: $ 758.65万
• 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 2013-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8534635
• 关键词: Accounting; Address; Adult; Authorization documentation; Cancer Therapy Evaluation Program; Clinical; Clinical Data Update System; Clinical Research; Clinical Treatment; Clinical Trials; Common Terminology Criteria for Adverse Events; Communication; Community Clinical Oncology Program; Comprehensive Cancer Center; Computers; Confidentiality; Contractor; Cooperative Group Program; Data; Development; Electronics; Extensible Markup Language; Extramural Activities; Funding; Informatics; Information Systems; Information Technology; Malignant Childhood Neoplasm; Malignant Neoplasms; Malignant neoplasm of brain; Monitoring Clinical Trials; Pathway interactions; Patients; Pediatric Oncology; Pharmaceutical Preparations; Process; Protocols documentation; Recovery; Regulatory Affairs; Reporting; Research Personnel; Resources; Safety; Security; Site; Speed; Support Contracts; System; Technology; Time; TimeLine; Translating; cancer diagnosis; cancer therapy; experience; improved; instrument; novel; oncology; operation; programs; protocol development; therapy development; tool; treatment trial; web page; web-enabled

Cancer Therapy Evaluation Programs Informatics and Computer Support of Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW). The Division of Cancer Treatment and Diagnosis (DCTD), primarily through its Cancer Therapy Evaluation Program (CTEP), sponsors several unique mechanisms to carry out early anticancer therapy development. The mechanisms encompass many of the nation's leading NCI-designated Comprehensive Cancer Centers, NCI's Cooperative Group programs 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 Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program is focused on accelerating progress by speeding the development of approximately 30 new clinical treatment trials. The accelerated timeline is possible due to the resources provided by ARRA. ARRA funds will assist NCI staff in supporting the accelerated timeline for mounting these 30 clinical trials. Funds will be added to CTEP support contracts including the Cancer Therapy and Evaluation Program's Informatics and Computer Support Contract. 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

癌症治疗评估项目加速肿瘤新途径临床试验的信息学和计算机支持(ActNow)。 癌症治疗和诊断部(DCTD)主要通过其癌症治疗评估计划(CTEP)，赞助几个独特的机制来开展早期抗癌治疗开发。这些机制包括许多由NCI指定的全国领先的综合癌症中心、NCI在成人和儿童肿瘤学方面的合作小组计划(在每个州都有参与地点)以及致力于脑和儿童癌症研究的专门肿瘤学联盟。新的肿瘤路径加速临床试验(ActNow)计划的重点是通过加快近30项新的临床治疗试验的开发来加快进展。由于ARRA提供的资源，加速的时间表是可能的。ARRA基金将帮助NCI的工作人员支持加快启动这30项临床试验的时间表。资金将被添加到CTEP支持合同中，包括癌症治疗和评估计划的信息学和计算机支持合同。 癌症治疗评价计划的企业系统(CTEP Esys)目前由22个模块组成，这些模块包括但不限于：临床试验监测部门审计信息系统(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(CDU)、Web使能CDU、通用毒性标准交互工具(CTCAE)、不良药物体验电子报告系统(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)、临床研究部门信息系统和临床IT(CIBISCIT)、监管事务处信息跟踪系统(RABITS)、文件管理、汇编、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。？消除整个肿瘤学社区的数据冗余？简化临床研究操作。？减轻NCI工作人员、承包商和外部研究人员的行政负担。？改善反恐方案与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保密性。增加所有研究人员获得临床试验的机会利用XML和其他技术，最大限度地提高可重用性并与肿瘤学社区中的其他系统集成。？支持患者广泛参与临床试验。？加快临床试验组织和审查机构内的方案制定和审查进程