Clinical Protocol and Data Management/Clinical Trials Office (Core 016)

临床方案和数据管理/临床试验办公室（核心 016）

• 批准号: 9753976
• 负责人: Antoinette Wozniak
• 金额: $ 52.97万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9753976
• 关键词: Academic Medical Centers; Advocacy; African American; Age; Automation; Awareness; Cancer Burden; Cancer Center; Cancer Center Support Grant; Cancer Control; Catchment Area; Clinical; Clinical Data; Clinical Investigator; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communication; Communities; Community Networks; Conduct Clinical Trials; Data; Databases; Dedications; Development; Doctor of Philosophy; Education; Ensure; Ethnic Origin; Evaluation; Familiarity; Female; Funding; Generations; Goals; Health; Hematologic Neoplasms; Hospitals; Individual; Industry; Infrastructure; Investigational Therapies; Knowledge; Lead; Leadership; Location; Malignant Childhood Neoplasm; Malignant Neoplasms; Medical; Medical Oncologist; Mission; Monitor; National Clinical Trials Network; Online Systems; Parents; Patients; Pediatric Hospitals; Pediatric Oncology; Pennsylvania; Play; Process; Protocol Compliance; Protocols documentation; Publishing; Race; Reporting; Research; Research Personnel; Safety; Science; Site; Time; Training; Training and Education; Trust; Underserved Population; Universities; University of Pittsburgh Cancer Institute; Update; barrier to care; base; clinical investigation; data management; design; health equity; improved; investigator-initiated trial; male; member; novel; oncology; programs; screening; standard of care

Abstract: Clinical Protocol and Data Management (CPDM) Clinical Protocol and Data Management (CPDM) is made up of 131staff members (as of June 2014) who facilitate development, implementation, coordination, internal data monitoring, and completion of approximately 250 oncology-focused trials at UPCI and UPMC CC each year. These include UPCI institutional (i.e., investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. Since 2008, CPDM oversight has been provided by the UPCI Associate Director for Clinical Investigation, Adam Brufsky, MD, PhD (BOCP), a board-certified medical oncologist. Deidre Cleary, BSN, RN, was appointed as the Director of CPDM in March 2012, and Rita Johnson, RN, was appointed as the Associate Director of CPDM in May 2013. As the central location for information on all cancer protocols, CPDM uses the Clinical Trials Management Application (CTMA) database to provide UPCI clinical investigators and review and monitoring committees with updated lists of all currently active protocols, status reports of individual planned and active protocols, and other critical clinical trial reports. To enhance staff training, improve protocol compliance, and facilitate internal and external audits, the CPDM QA/QC, Education, and Compliance Department was implemented during the past Cancer Center Support Grant (CCSG) funding period. The specific aims of CPDM are to: 1) Develop the National Clinical Trials Network Lead Academic Participating Site and Experimental Therapeutics-Clinical Trials Network Lead Academic Organization at UPCI. 2) Increase accruals to novel investigator-initiated trials, and enhance availability of trials throughout network sites; 3) Streamline pre-submission and protocol design and review infrastructure in order to decrease the time to clinical trial activation, 4) Evaluate, review, and solidify the formal internal education, training, and compliance programs for clinical researchers, 5) Continue to strengthen the Data Safety Monitoring Committee through expert leadership and improved reporting processes; 6) Enhance regular communication between all cancer-related research departments within the large academic medical center and university, 7) Continue to enhance the web-based Clinical Trials Management Application to allow for greater automation of processes and improved data capture, safety compliance, and report generation, 8) Build trust, comfort and familiarity between the UPCI and UPMC CC and underserved populations, most notably African Americans, and decrease disparities through community based educational programs and screening, 9) Increase knowledge of and access to clinical research among African American communities by identifying and removing barriers to care and patient navigation, 10) Increase awareness, among parents and other concerned individuals, that clinical trials are the standard of care for children with cancer and hematologic malignancies, and 11) Maintain our long-standing relationship with the Pennsylvania Department of the Health to ensure implementation and evaluation of the recently published 2013-2018 Pennsylvania Cancer Control Plan in the UPCI catchment area.

摘要：临床方案和数据管理（CPDM） 临床方案和数据管理（CPDM）由131STAFF成员（截至2014年6月）组成 促进开发，实施，协调，内部数据监控和完成大约完成 每年在UPCI和UPMC CC进行250个以肿瘤学为重点的试验。这些包括UPCI机构（即 研究人员发起的），多中心合作集团/国家临床试验网络（NCTN），财团和财团和 行业赞助的试验。自2008年以来，UPCI副主任提供了CPDM监督 临床调查，医学博士Adam Brufsky，博士（BOCP），董事会认证的医学肿瘤学家。 Deidre Cleary， RN BSN于2012年3月被任命为CPDM的董事，RN的Rita Johnson被任命为 CPDM副主任于2013年5月作为有关所有癌症方案的信息的中心地点， CPDM使用临床试验管理应用程序（CTMA）数据库提供UPCI临床 调查人员并审查和监视委员会，并具有所有当前有效协议的最新列表，状态 个人计划和主动方案以及其他关键临床试验报告的报告。加强员工 培训，提高协议合规性并促进内部和外部审核，CPDM QA/QC，教育， 在过去的癌症中心支持补助金（CCSG）资金中实施了合规部 时期。 CPDM的具体目的是：1）开发国家临床试验网络负责 参与网站和UPCI的实验性治疗临床试验网络领导学术组织。 2）将应计入量增加到新的研究者发起的试验，并提高整个网络的试验的可用性 站点； 3）简化预选和协议设计和审查基础架构，以减少 临床试验激活的时间，4）评估，审查和巩固正式的内部教育，培训和 临床研究人员的合规计划，5）继续加强数据安全监测委员会 通过专家领导和改进的报告过程； 6）增强所有人之间的常规沟通 大型学术医学中心和大学内与癌症相关的研究部门7）继续 增强基于Web的临床试验管理应用程序，以允许更大的流程自动化 并改善数据捕获，安全合规性和报告生成，8）建立信任，舒适和熟悉 在UPCI和UPMC CC以及服务不足的人群之间，最著名的是非裔美国人，以及 通过基于社区的教育计划和筛查来减少差异，9）增加对 并通过识别和消除障碍来获得非裔美国人社区的临床研究 护理和患者导航，10）在父母和其他有关个人中，提高认识 临床试验是癌症和血液学恶性肿瘤儿童的护理标准，11）维持 我们与宾夕法尼亚州卫生部的长期关系，以确保实施和 对最近发布的2013 - 2018年宾夕法尼亚州癌症控制计划的评估。