Clinical Trials and Information Management Support

该项目是为美国国家癌症研究所(NCI)癌症治疗评估计划(CTEP)而开展的，自1981年以来一直得到Emmes公司的持续支持，并对各种不断变化的CTEP需求做出了回应。支助实际上分为两部分：任务一根据需要向临床研究处和国家癌症咨询委员会(NCAB)的临床试验工作组(CTWG)的工作人员提供信息支持和数据库管理，以及协调科学指导委员会的活动；任务二为外部/小组间试验提供数据管理、统计支持和业务办公室的要求；该试验以前包括由CTEP赞助的扩大准入试验，目前涉及跟踪继发恶性肿瘤。这两项任务都有助于CTEP完成协调和管理复杂而全面的国家癌症临床研究计划的中心任务。更具体地说，任务一的活动包括汇编、整理、总结和分析由反恐方案赞助的合作组调查员收集的数据，以及文献和数据库搜索和检索。此外，EMMES工作人员创建和/或维护数据库以跟踪有关NCI赞助的临床试验的信息；这包括CIB信息学系统/临床信息跟踪(CIBISCIT)数据库的协议摘要、对CTEP成果数据库的审查和其他支持、开发每半年一次的NCI临床试验合作小组全国会议报告，以及开发和标准化NCI的公共数据元素工作的变量元素，该工作建立了用于所有NCI赞助试验的通用命名法。这项任务还支持协调CTEP的概念审查会议(CRM)进程，并自2006年以来为集团间科学委员会向更广泛、更具包容性的科学指导委员会及其工作队过渡提供了协调和信息支持。这些科学指导委员会审查将在合作组和社区临床肿瘤学计划临床试验基础设施内进行的第三阶段癌症临床试验的概念。目前，他们有8个科学指导委员会和40多个相关工作队，为会议、会议记录、信息汇编、协作工具、手稿和其他需要提供支助。除了目前在胃肠癌、妇科癌症、头颈癌、泌尿生殖系癌症和其他正在开发的领域为特定疾病的科学指导委员会和特别工作组提供的支持外，还有由十个特别工作组和三个工作组组成的调查药物指导委员会、症状管理和生活质量指导委员会以及患者倡导指导委员会。还为恶性血液病和乳腺癌群体间提供了支持。任务II下的过去活动包括担任扩大参与项目(EPP)的临床试验管理股，以及CTEP管理的治疗转诊中心(TRC)和C组方案的数据协调中心。EPP是癌症试验支助股(CTSU)的试点项目，而TRC和C组机制涉及大量富有同情心的研究，需要方案准备和设计、随机化、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，还支持淋巴瘤和黑色素瘤疫苗的两个第三阶段研究。目前，在任何由CTEP支持的临床试验中，都为追踪二次AMS/MDS治疗提供了数据管理和统计支持。

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.