Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10319049
• 负责人: Evan Yu
• 金额: $ 70.12万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10319049
• 关键词: Active Learning; Cancer Center Support Grant; Catchment Area; Child; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Communication; Community Outreach; Data; Data Reporting; Diagnosis; Enrollment; Ensure; Fostering; Good Clinical Practice; Growth; Hispanic; Hispanic Populations; Individual; Infrastructure; Institution; Intervention; Intervention Studies; Intervention Trial; Malignant Neoplasms; Minority; Minority Health Research; Monitor; National Clinical Trials Network; Pediatric Oncology; Pediatric Oncology Group; Peer Review; Policies; Population; Process; Progress Reports; Protocol Compliance; Publications; Quality Control; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Risk; Rural Community; Safety; System; Time; Training and Education; Trust; Underserved Population; United States National Institutes of Health; Universities; Washington; Woman; anticancer research; base; clinically relevant; community engagement; data integrity; data management; demographics; member; minority children; oncology trial; participant enrollment; patient population; patient safety; pediatric patients; protocol development; quality assurance; racial minority; ranpirnase; real time monitoring; recruit; repository; research study; treatment trial; trial comparing

PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) Part I: Clinical Research Support (CRS). CRS includes 65 FTEs who provide centralized support for the conduct of cancer-related clinical research on behalf of the all Consortium institutions. The integrated CRS provides the infrastructure and processes to efficiently and effectively support over 176 Consortium investigators on all cancer clinical research studies and serves as the central repository of clinical research information. In FY 2018, CRS reported the recruitment of 10,716 individuals onto all clinical research studies (5,424 interventional and 5,292 non-interventional accruals) and facilitated activation of 180 studies (150 interventional), including 66 institutional and externally peer-reviewed studies. Part II: Data and Safety Monitoring (DSM). DSM is required for all interventional studies. For investigator-initiated studies, a well-established internal Data and Safety Monitoring Committee (DSMC) performs risk-based monitoring to ensure the highest levels of patient safety. In addition, effective quality control functions promote protocol compliance in accordance with sponsor requirements and the NCI- approved Consortium Data Safety Monitoring Plan (DSMP). In FY 2018, the DSMC monitored 118 studies, which included the review of 58 reports from study-specific DSMBs. Part III: Inclusion of Women and Minorities in Research. The Consortium leads multiple, proactive efforts to promote the recruitment of women and minorities. In FY 2018, among the 5,424 individuals enrolled onto interventional studies, 61% were women and enrollments consisted of 10% ethnic Hispanics and 23% non-White racial minorities, which compares favorably to catchment area demographics of 50% women, 10% Hispanic, and 24% non-White racial minorities. Part IV: Inclusion of Children in Research. The Consortium supports the NIH policy on the inclusion of children in research. The Consortium is an active member of the National Clinical Trials Network (NCTN) Children’s Oncology Group and several other national pediatric oncology trial consortia. Enhancements to our Children’s clinical research infrastructure have supported significant growth in Consortium enrollments. In FY 2018, 153 of the 286 (54%) newly registered pediatric patients enrolled on an interventional treatment trial compared to 85 of 240 (35%) in FY 2014. An additional 296 children were accrued to interventional non-treatment trials in FY 2018, up from 195 in FY 2014.

项目摘要：临床协议和数据管理（CPDM） 第一部分：临床研究支持（CRS）。 CRS包括65英尺 代表所有联盟机构的癌症相关临床研究进行。集成的CRS 提供基础架构和过程，以有效有效地支持176个财团 所有癌症临床研究的研究者，并作为临床研究的中心库 信息。在2018财年，CRS报道了10,716个人在所有临床研究中招募 （5,424次介入和5,292次非际交往量），并制备了180项研究的激活（150 介入），包括66个机构和外部同行评审研究。 第二部分：数据和安全监控（DSM）。所有介入研究都需要DSM。为了 研究人员发动的研究是一个公认的内部数据和安全监测委员会（DSMC） 进行基于风险的监控，以确保患者安全的最高水平。另外，有效的质量 控制功能根据赞助商的要求和NCI-促进协议合规性 批准的联盟数据安全监控计划（DSMP）。在2018财年，DSMC监测了118项研究， 其中包括对研究特定DSMB的58个报告的审查。 第三部分：将妇女和少数民族纳入研究。该财团带领多个主动 努力促进妇女和少数民族的招募。在2018财年，在5,424个人中 参加介入研究，有61％是女性，入学人数包括10％的西班牙裔民族 和23％的非白人种族少数群体，这与50％的集水区人口统计相比 妇女，10％的西班牙裔和24％的非白人种族少数民族。 第四部分：将儿童纳入研究。该财团支持NIH政策有关的政策 研究中的孩子。该财团是国家临床试验网络（NCTN）的活跃成员 儿童肿瘤学小组和其他几个国家儿科肿瘤学试验财团。增强 我们儿童的临床研究基础设施支持了财团入学率的显着增长。 在2018财年，286名（54％）新注册的小儿患者接受了介入治疗 试验比2014财年的240个中有85个（35％）。 2018财年的非治疗试验，比2014财年的195财年为止。