Clinical Trials and Information Management Support

该项目是为美国国家癌症研究所（NCI）癌症治疗评估项目（CTEP）开展的，自1981年以来一直得到EMMES公司的支持，并对各种不断变化的CTEP需求做出了反应。支持实际上分为两个部分：任务I根据需要为临床研究分支和CTEP其他分支的工作人员提供信息支持和数据库管理，以及协调国家癌症咨询委员会（NCAB）临床试验工作组（CTWG）授权的科学指导委员会的活动;任务II为院外/组间试验提供数据管理、统计支持和运营办公室要求，这些试验之前包括由CTEP申办的扩大使用试验，目前涉及跟踪继发性恶性肿瘤。这两项任务都有助于CTEP完成其协调和管理复杂而全面的国家临床癌症研究计划的中心使命。更具体地说，任务I活动包括编辑，整理，总结和分析CTEP赞助的合作组调查人员收集的数据，以及文献和数据库的搜索和检索。此外，EMMES工作人员创建和/或维护数据库，以跟踪有关NCI申办的临床试验的信息;这包括CIB信息系统/临床信息跟踪协议的抽象（CIBISCIT）数据库，对CTEP成就数据库进行审查和其他支持，制定半年度NCI临床试验合作组全国会议报告，以及NCI通用数据元素工作的可变元素的开发和标准化，该工作建立了用于所有NCI申办的试验的通用术语。这项任务还支持协调CTEP的概念审查会议进程，并自2006年以来扩大了协调和信息支持，以促进集团间科学委员会过渡到更广泛、更具包容性的科学指导委员会结构及其工作队。这些科学指导委员会审查将在合作组和社区临床肿瘤学项目临床试验基础设施内进行的III期癌症临床试验的概念。目前，有八个科学指导委员会和四十多个相关的工作队正在为会议、会议记录、信息汇编、协作工具、手稿和其他需求提供支持。除了目前在胃肠癌、妇科癌、头颈癌、泌尿生殖系统癌和其他正在发展的领域为特定疾病科学指导委员会和工作队提供的支持外，还有研究药物指导委员会，下设10个工作队和3个工作组，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团体提供支助。任务II下的过去活动包括担任扩大参与项目（EPP）的临床试验管理单位，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作为癌症试验支持单位（CTSU）的试点项目，TRC和C组机制涉及大量的同情研究，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，还支助了两项关于淋巴瘤和黑色素瘤疫苗的第三阶段研究。目前，在任何CTEP支持的临床试验中，为跟踪辅助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.