Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10267050
• 负责人: Ashkan Emadi
• 金额: $ 27.4万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-08 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10267050
• 关键词: Age-Years; Architecture; Asians; Baltimore; Biometry; Cancer Center Support Grant; Catchment Area; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Complement; Comprehensive Cancer Center; Data; Data Collection; Databases; Disease; Doctor of Medicine; Doctor of Philosophy; Enrollment; Ensure; Equipment and supply inventories; Flow Cytometry; Focus Groups; Fostering; Funding; Genomics; Grant; Human; Human Resources; Image; Individual; Industry; Information Technology; Institutes; Intervention; Intervention Trial; Investigational Therapies; Laboratories; Leadership; Longevity; Malignant Neoplasms; Maryland; Measures; Medical; Medical center; Minority; Mission; Modality; Molecular Biology; Monitor; National Cancer Institute; Nurses; Office Management; Oncology; Pathology; Patients; Peer Review; Phase; Play; Population Sciences; Protocols documentation; Quality Control; Reporting; Research; Research Activity; Research Personnel; Safety; Services; Site; System; Therapeutic Trials; Time; Underrepresented Minority; Universities; Wages; Woman; Work; acronyms; biobank; cancer clinical trial; cancer therapy; clinical implementation; college; cost; cost effective; data management; data quality/integrity; health disparity; health equity promotion; hormone related cancer; improved; innovation; investigator-initiated trial; medical schools; member; minimal risk; neoplasm immunotherapy; oncology trial; operation; participant enrollment; patient oriented; patient safety; pediatric patients; phase I trial; phase II trial; programs; protocol development; quality assurance; structural biology; tumor immunology; virology

7.0. Abstract: Clinical Protocol and Data Management Clinical Protocol and Data Management (CPDM): The Clinical Research Management Office (CRMO) provides clinical trial management services to more than 35 investigators and oversees high-quality conduct and reporting of all cancer clinical trials at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) and the University of Maryland network sites. Comprising more than 50 full-time equivalent personnel, CRMO works closely with UMGCCC Disease/Modality Focused Groups (DFG) to manage a robust cancer clinical trial portfolio that prioritizes institutionally and externally peer-reviewed trials and complements UMGCCC's patient catchment area. CRMO utilizes the OnCore® database to track the conduct of and patient accrual to all oncology clinical trials and to centrally report clinical research activities to UMGCCC leadership. During the last grant period (CY2015–2019), CRMO supported the activation of 381 interventional clinical trials, resulting in 2,029 interventional trial enrollments during the reporting period. During FY2019, costs to support CPDM were $4,569,709, of which $204,148 were funded by the CCSG. Data and Safety Monitoring: UMGCCC's Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) serves the data safety monitoring function for protocols that do not have an external data and safety monitoring board (DSMB). The DSM/QAC annually reviews safety information for patients accrued to all oncology protocols considered “greater than minimal risk,” as defined in the UMGCCC-approved DSM Plan. This includes investigator-initiated trials of any phase, all Phase I trials, and selected industry Phase II trials without a sponsor- appointed DSMB, as well as multi-institutional, investigator-initiated trials for which UMGCCC is the coordinating center. During FY2019, costs to support DSM/QAC were $93,938, of which $23,592 were funded by the CCSG. This funding supported the annual review of 344 trials during the reporting period, as well as a percentage of salaries for three staff members. Inclusion of Women and Minorities in Clinical Research: UMGCCC continues to demonstrate a robust enrollment of women and minorities into clinical trials. Among the 2,029 people enrolled into interventional trials from CY2015–CY2019, 1,146 (56 percent) were women. Overall minority accrual to clinical trials is 56 percent. This includes 48.2 percent underrepresented minorities as well as 7.8 percent Asians, the latter reflecting clinical trials examining health disparities in that group. Underrepresented minority accrual to therapeutic trials is 34.7 percent. Inclusion of Individuals Across the Life Span in Clinical Research: UMGCCC is strongly committed to including individuals across the life span into clinical research. Of the 2,029 people enrolled into interventional trials from CY2015–CY2019, 448 (22 percent) were older than 65 years of age, and an average of 17 percent of all new UMGCCC pediatric patients were enrolled into interventional trials annually.

7.0版本。摘要：临床方案和数据管理 临床方案和数据管理(CPDM)：临床研究管理办公室(CRMO) 为超过35名研究人员提供临床试验管理服务，并监督高质量的行为和 马里兰大学马琳分校和斯图尔特·格林鲍姆分校所有癌症临床试验报告 综合癌症中心(UMGCCC)和马里兰大学网络网站。由多于 50名全职同等人员，CRMO与UMGCCC疾病/医疗保健重点小组(DFG)密切合作 管理强大的癌症临床试验组合，优先考虑机构和外部同行评审的试验 并补充了UMGCCC的病人收集区。CRMO利用OnCore®数据库来跟踪 所有肿瘤学临床试验的进行和患者应计费用，并集中报告临床研究活动 UMGCCC领导层。在上一次赠款期间(2015-2019年)，CRMO支持激活了381 在本报告所述期间，共进行了2 029项干预试验。在.期间 2019财年，支持CPDM的费用为4569,709美元，其中204,148美元由CCSG提供资金。数据和 安全监控：UMGCCC的数据安全监控/质量保证委员会(DSM/QAC)为 没有外部数据和安全监控板的协议的数据安全监控功能 (Dsmb)。DSM/QAC每年审查所有肿瘤学方案所积累的患者的安全信息 如UMGCCC批准的需求侧管理计划中所定义的，被认为“大于最小风险”。这包括 研究人员发起的任何阶段的试验、所有第一阶段试验和选定的行业第二阶段试验，而没有赞助商- 指定的dsmb，以及由UMGCCC协调的多机构、由调查员发起的试验 中间。在2019财年，支持DSM/QAC的成本为93,938美元，其中23,592美元由CCSG提供资金。 在本报告所述期间，这笔资金支持了对344项试验的年度审查，以及 三名工作人员的薪金。将妇女和少数族裔纳入临床研究：UMGCCC 继续显示妇女和少数族裔参加临床试验的情况强劲。在2029人中 2015-2019财年登记参加干预试验的1146人(56%)是女性。总体少数 临床试验的应计利润为56%。这包括48.2%的代表性不足的少数族裔以及7.8%的少数民族 亚洲人的百分比，后者反映了检查这一群体健康差异的临床试验。任职人数不足 治疗试验的少数收益为34.7%。将不同生命周期的个体纳入临床 研究：UMGCCC坚定地致力于将整个生命周期的个体纳入临床研究。的 2015-2019财年参加干预试验的2029人中，有448人(22%)年龄在65岁以上 年，所有新的UMGCCC儿科患者中平均有17%参加了 每年进行一次介入试验。