CLINICAL PROTOCOL AND DATA MANAGEMENT

临床方案和数据管理

• 批准号: 7414807
• 负责人: PETER D. EMANUEL
• 金额: $ 40.6万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7414807
• 关键词: Adherence; Cancer Center; Caring; Clinical; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Trials; Conduct Clinical Trials; Data; Data Collection; Databases; Development; Disease; Doctor of Medicine; Eastern Cooperative Oncology Group; Enrollment; Extramural Activities; Faculty; Funding; Industry; Leadership; Monitor; Monitoring Clinical Trials; Numbers; Nurses; Nursing Protocols; Operative Surgical Procedures; Patients; Pharmacy facility; Phase I/II Trial; Physician Executives; Physicians; Play; Procedures; Protocols documentation; Reproduction spores; Research; Research Personnel; Role; Site; Toxic effect; cancer research center director; data management; improved; quality assurance

DESCRIPTION (provided by applicant): The overall aims of the Clinical Protocol and Data Management Shared (CPDM) Facility are to: a) provide central management for the implementation, coordination, and conduct of clinical trials developed by the UAB Cancer Center faculty and by our extramural collaborators associated with SPOREs, other Cancer Centers, the NCI, industry and cooperative groups, b) provide for quality assurance of the operation including monitoring of toxicities, clinical care, data collection, and adherence to protocol-described procedures, c) provide a centralized database of protocol-specific data, and d) provide research pharmacy support for the acquisition, storage, dispensing, and tracking of all investigational agents administered to protocol patients as required by the protocol and regulatory agencies (local, state, and national). Major accomplishments since last submission have included: a) An increment of 28% in the 4 year accrual of patients in the CPDM Facility. This patient accrual includes a total of 1047 patients to investigator initiated trials (34% of the total accrual) and 1305 patients to Phase I and II trials (42% of the total accrual), b) Implementation of the Clinical Trials Monitoring Committee (CTMC) which meets weekly and monitors every active clinical trial in the Cancer Center, c) Development of specialized Protocol Management Teams consisting of nurse protocol coordinators and data managers to improve their disease specific expertise, enhance nurse-physician interaction and to increase the number of patients enrolled in the high priority studies, d) During this funding period, the Cancer Center played a central role in recruitment of 16 clinical investigators to UAB clinical Divisions and Departments. These recruitments ncluded the Deputy Director of the Cancer Center (Dr. Bland), Associate Director for Clinical Research (Dr. Rinehart) and Medical Director of the CPDM Facility (Dr. Forero). e) In 2002, we developed full ECOG membership under the leadership of Carla Falkson, M.D. In 2003, our first year of full membership we became the leading accrual site for ECOG with over 100 registrations.

描述（由申请人提供）：临床方案和数据的总体目标 管理共享 (CPDM) 设施将： a) 为 UAB 癌症中心教员以及与 SPORE、其他癌症中心、NCI、行业和机构相关的校外合作者开发的临床试验的实施、协调和进行提供中央管理。合作小组，b) 提供操作质量保证，包括毒性监测、临床护理、数据收集和遵守方案描述的程序，c) 提供方案特定数据的集中数据库，以及 d) 提供研究药房根据方案和监管机构（地方、州和国家）的要求，支持对方案患者施用的所有研究药物的采集、存储、分配和跟踪。 自上次提交以来的主要成就包括： a) CPDM 设施的 4 年患者数量增加了 28%。 该患者应计包括总共 1047 名患者参加研究者发起的试验（34% 总应计费用）和 1305 名患者参加 I 期和 II 期试验（占总应计费用的 42%），b) 实施临床试验监测委员会 (CTMC)，该委员会每周举行一次会议，监测癌症中心的每一项正在进行的临床试验，c ) 建立由护士方案协调员和数据管理人员组成的专业方案管理团队，以提高他们的疾病具体专业知识，加强护士与医生的互动，并增加参加高优先级研究的患者数量， d) 在此资助期间，癌症中心在 UAB 临床部门和科室招募 16 名临床研究者方面发挥了核心作用。 这些招聘人员包括癌症中心副主任（Bland 博士）、临床研究副主任（Rinehart 博士）和 CPDM 设施的医疗主任（Forero 博士）。 e) 2002 年，我们在医学博士 Carla Falkson 的领导下发展了 ECOG 正式会员资格。2003 年，即我们成为正式会员的第一年，我们成为 ECOG 领先的累积网站，注册人数超过 100 人。