Shared Resources-Clinical Research Services

共享资源-临床研究服务

• 批准号: 8312368
• 负责人: William K. Kelly
• 金额: $ 13.84万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8312368
• 关键词: Area; Biometry; Budgets; Clinical; Clinical Investigator; Clinical Nursing Research; Clinical Protocols; Clinical Research; Clinical Trials; Communication; Communities; Comprehensive Cancer Center; Conduct Clinical Trials; Contracts; Data; Databases; Development; Enrollment; Ensure; Faculty; Growth; Guidelines; Human; Human Resources; Industry; Institutional Review Boards; Investigational Drugs; Knowledge; Lead; Leadership; Measures; Mediation; Mission; Monitor; Oncologist; Patients; Phase; Protocol Compliance; Protocols documentation; Qualifying; Quality Control; Reporting; Research Infrastructure; Research Personnel; Resource Sharing; Resources; Safety; Schedule; Screening procedure; Services; Structure; Testing; Therapeutic; Time; Training; Training and Education; Translational Research; Work; Yale Cancer Center; biomedical informatics; data management; design; experience; innovation; meetings; member; oncology; operation; protocol development; quality assurance; skills; tool

The Clinical Trials Office has grown substantially during the current project period, in terms of number of clinical investigators served, the number of investigator-initiated studies and the support personnel who enable clinical trials at the Yale Cancer Center (YCC). To meet the growing needs of the investigators and YCC's mission of promoting translational and clinical research, the Clinical Trials Office has been restructured and renamed the Clinical Research Services (CRS). The CRS is a YCC Shared Resource that provides centralized management of all clinical trials conducted at the YCC. It provides support for the development, implementation, and management of human-investigational studies with a particular focus on developing and managing early phase investigator-initiated studies. To meet these objectives, the GRS has been re-organized into five distinct and specialized support units with dedicated personnel (protocol development, budgets and contracts, data management, investigational new drugs, and clinical research nursing) to provide an integrated, highly coordinated set of resources that can efficiently and effectively support the conduct of clinical studies. This resource provides the infrastructure necessary to support translational research and high-quality clinical trials. The CRS is directed by Dr. W. Kevin Kelly, whose knowledge, experience, expertise, leadership and managerial skills make him particularly well qualified to serve as CRS Director. The CRS interacts closely with other YCC Shared Resources, especially Biostatistics and Biomedical Informatics, to facilitate protocol design, development, and monitoring. The CRS also works closely with the YCC Office of Protocol Review and Monitoring in implementing quality control and assurance measures as well as identifying areas of need for training and education that lead to improvement of operations. In addition, the CRS ensures compliance with the YCC Data and Safety Monitoring Plan. At the time of this submission, 48 clinical therapeutic protocols are open and monitored by the CRS (31% investigator-initiated; 35% industry-sponsored; 33% cooperative group). The number of new trials activated in 2006 was 14, of which 5 were investigator-initiated. As the number of YCC clinical investigators has increased along with growth of oncology faculty, numbers of patients, and number of active studies, the usage of the CRS has increased significantly. The CRS is structured and directed in a manner that efficiently facilitates the conduct of innovative, investigator-initiated clinical trials.

在当前项目期间，临床试验办公室在为临床研究人员提供服务的数量、由研究人员发起的研究数量以及在耶鲁癌症中心(YCC)进行临床试验的支持人员方面都有了显著的增长。为了满足研究人员日益增长的需求和YCC促进翻译和临床研究的使命，临床试验办公室进行了重组，并更名为临床研究服务(CRS)。CRS是YCC共享资源，提供对YCC进行的所有临床试验的集中管理。它为人类调查研究的开发、实施和管理提供支持，特别侧重于开发和管理由调查员发起的早期研究。为了实现这些目标，GRS已经 已重组为五个不同的专门支助单位，配备专职人员(方案制定、预算和合同、数据管理、研究新药和临床研究护理)，以提供一套综合的、高度协调的资源，能够高效率和有效地支持临床研究的开展。此资源提供支持所需的基础架构 转化研究和高质量的临床试验。CRS由W.Kevin Kelly博士担任主任，他的知识、经验、专业知识、领导力和管理技能使他特别有资格担任CRS主任。CRS与其他YCC共享资源，特别是生物统计和生物医学信息学密切互动，以促进协议设计、开发和监控。CRS还与YCC礼宾审查和监测办公室密切合作，实施质量控制和保证 采取措施以及确定需要培训和教育的领域，以改进业务。此外，CRS还确保遵守YCC数据和安全监控计划。 在提交本报告时，CRS正在开放和监测48个临床治疗方案(31%由研究人员发起；35%由行业发起；33%由合作组)。2006年启动的新审判数量为14项，其中5项是由调查员发起的。随着YCC临床研究人员的数量 随着肿瘤学教师、患者数量和积极研究数量的增加，CRS的使用量显著增加。CRS的结构和指导方式有效地促进了由研究人员发起的创新临床试验的进行。