Clinical Trials and Information Management Support

临床试验和信息管理支持

• 批准号: 7691882
• 金额: $ 134.1万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7691882
• 关键词: Clinical; Trials; Information; Management; Support

This project, undertaken for the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI), has been supported continuously by the EMMES Corporation since 1981 and has been responsive to a variety of changing CTEP needs. Support is effectively divided into two parts: Task I provides information support and database administration to the staff of the Clinical Investigations Branch and other branches of CTEP as required, as well as coordinating activities of Scientific Steering Committees as mandated by the Clinical Trials Working Group (CTWG) of the National Cancer Advisory Board (NCAB); Task II provides data management, statistical support, and operations office requirements for both extramural/intergroup trials, which has previously included expanded access trials sponsored by CTEP and currently involves tracking secondary malignancies. Both tasks assist CTEP in their central mission of coordinating and administering a complex and comprehensive national program of clinical cancer research. More specifically, Task I activities include compilation, collation, summarization, and analysis of data gathered by CTEP-sponsored Cooperative Group investigators, as well as literature and database searches and retrieval. In addition, EMMES staff creates and/or maintains databases to track information concerning NCI-sponsored clinical trials; this includes abstraction of protocols for the CIB Informatics System/Clinical Information Tracking (CIBISCIT) database, review and other support for the CTEP Accomplishments database, development of the semi-annual NCI's Clinical Trials Cooperative Groups National meeting Report, and development and standardization of variable elements for NCI's Common Data Element effort, which establishes a common nomenclature for use in all NCI-sponsored trials. This task also supports coordination of CTEP's Concept Review Meeting (CRM) process and since 2006 expanded coordination and informatics support for the transition of Intergroup Scientific Committees into a broader, more inclusive Scientific Steering Committee structure and their Task Forces. These Scientific Steering committees review concepts for phase III cancer clinical trials to be conducted within the Cooperative Group and Community Clinical Oncology Program clinical trial infrastructure. Currently their are eight Scientific Steering Committees and over forty associated Task Forces being provided support for meetings, minutes, information compilations, collaborative tools, manuscripts and other needs. In addition to current support provided for disease-specific Scientific Steering Committees and Task Forces in the areas of gastrointestinal cancer, gynecological cancer, head and neck cancer, genitourinary cancer and others areas under development, there is the Investigation Drug Steering Committee with ten Task Forces and three Working Groups, the Symptom Management and Quality of Life Steering Committee, and the Patient Advocate Steering Committee. Support is also provided for hematologic malignancies and breast cancer Intergroups. Past activities under Task II include serving as the Clinical Trials Management Unit for the Expanded Participation Project (EPP) and as the Data Coordinating Center for Treatment Referral Center (TRC) and Group C protocols administered by CTEP. The EPP served as a pilot project for the Cancer Trials Support Unit (CTSU), and the TRC and Group C mechanisms involved high-volume, compassionate studies requiring protocol preparation and design, randomization, data collection, data entry, data quality control, data analysis and reporting. Two phase III studies of vaccines for lymphoma and melanoma were also supported under the contract. Currently, data management and statistical support are provided for tracking secondary AMS/MDS treatment on any CTEP supported clinical trial.

该项目是为癌症治疗评估计划（CTEP），国家癌症研究所（NCI）进行的，自1981年以来一直受到艾米斯公司（Emmes Corporation）的不断支持，并且对各种不断变化的CTEP需求做出了反应。支持有效分为两个部分：任务I提供信息支持和数据库管理，并根据需要为CTEP的临床调查部门和其他CTEP的其他分支，以及由国家癌症咨询委员会（NCAB）（NCAB）的临床试验工作组（CTWG）规定的科学转向委员会的协调活动； Task II提供了两个校外/组间试验的数据管理，统计支持和运营办公室的要求，该试验以前包括CTEP赞助的扩展访问试验，目前涉及跟踪次要恶性肿瘤。这两项任务都有助于CTEP协调和管理一项复杂而全面的国家临床癌症研究计划的中心任务。 更具体地说，任务I活动包括由CTEP赞助的合作集团调查员收集的数据进行汇编，整理，汇总和分析，以及文献和数据库搜索和检索。此外，Emmes员工还创建和/或维护数据库，以跟踪有关NCI赞助的临床试验的信息； this includes abstraction of protocols for the CIB Informatics System/Clinical Information Tracking (CIBISCIT) database, review and other support for the CTEP Accomplishments database, development of the semi-annual NCI's Clinical Trials Cooperative Groups National meeting Report, and development and standardization of variable elements for NCI's Common Data Element effort, which establishes a common nomenclature for use in all NCI-sponsored trials.这项任务还支持CTEP概念审查会议（CRM）程序的协调，自2006年以来，扩大了对团体间科学委员会过渡到更广泛，更具包容的科学指导委员会结构及其工作队的协调和信息学支持。这些科学转向委员会回顾了有关在合作组和社区临床肿瘤计划临床试验基础设施中进行的III期癌症临床试验的概念。目前，他们是八个科学转向委员会，超过四十多个相关的工作队，为会议，会议记录，信息汇编，协作工具，手稿和其他需求提供了支持。除了为胃肠道癌地区的疾病特异性科学转向委员会和工作组提供的目前支持外，妇科癌，头颈癌，头颈癌，泌尿生殖器癌和正在开发的其他领域，还有十个工作组和三个工作组的调查药物指导委员会，三个工作组，三个工作组，症状管理和生活质量指导委员会以及患者倡导委员会。还为血液系统恶性肿瘤和乳腺癌间提供了支持。 任务II下的过去活动包括作为扩展参与项目（EPP）的临床试验管理部门以及CTEP管理的数据协调中心（TRC）和C组协议。 EPP是癌症试验支持单位（CTSU）的试点项目，TRC和C组机制涉及大量，富有同情心的研究，需要协议准备和设计，随机分配，数据收集，数据输入，数据质量控制，数据分析和报告。根据合同，还支持了淋巴瘤和黑色素瘤疫苗的两期研究。当前，在任何支持的CTEP支持的临床试验中，提供了用于跟踪次级AMS/MDS治疗的数据管理和统计支持。