Clinical Protocol and Data Management

临床方案和数据管理

基本信息

批准号：
10204901
负责人：
SUSANNE M ARNOLD
金额：
$ 20.91万
依托单位：
UNIVERSITY OF KENTUCKY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-07-08 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10204901
关键词：
Adherence African American Appalachian Region Biometry Cancer Center Cancer Center Support Grant Catchment Area Child Clinical Clinical Cancer Center Clinical Data Clinical Management Clinical Medicine Clinical Protocols Clinical Research Clinical Research Associate Clinical Trials Conduct Clinical Trials Data Data Collection Data Management Resources Devices Disease Doctor of Pharmacy Ensure Ethnic Origin Female Funding Agency Gender Genomics Goals Guidelines Hispanics Histologic Incidence Institution Institutional Review Boards Intervention Investigation Investigational Drugs Kentucky Latino Leadership Maintenance Malignant Childhood Neoplasm Malignant Neoplasms Malignant neoplasm of prostate Minority Mission Monitor NCI Center for Cancer Research National Cancer Institute National Clinical Trials Network Nephroblastoma Neuroblastoma Nurses Participant Pediatric Hematology Pediatric Oncology Pediatric Oncology Group Peer Review Performance Physician Executives Primary carcinoma of the liver cells Procedures Protocol Compliance Protocols documentation Race Reporting Research Research Activity Research Personnel Research Priority Resource Allocation Resource Sharing Risk Safety Services Special Population Supervision System Toxic effect Training Translational Research United States Food and Drug Administration United States National Institutes of Health Universities Vision Woman anticancer research base cancer clinical trial clinical care clinical translation data management design experience improved industry partner informatics shared resource investigator-initiated trial leukemia/lymphoma malignant breast neoplasm minority children operation osteosarcoma patient safety precision medicine protocol development quality assurance response support tools working group

项目摘要

PROJECT SUMMARY/ABSTRACT Part I: Clinical Protocol and Data Management (CPDM). CPDM facilitates all clinical cancer research at the Markey Cancer Center (MCC) and is responsible for an increase to over 1,000 interventional accruals per year and 9,357 interventional accruals over the reporting period. The CPDM has 3 major components: the Clinical Research Office (CRO), the Quality Assurance (QA) Office and the MCC Data and Safety Monitoring Plan (DSMP). Oversight is provided by the Associate Director for Clinical Translation, Susanne Arnold, MD (DT), who supervises the CRO Medical Director (Jonathan Feddock, MD [DT]) and the Precision Medicine Center (PMC) Director (Jill Kolesar, PharmD, MS [DT]), assisted by the Associate Director for Administration (David M. Gosky, MA, MBA). The CRO consists of 4 operational units: Finance, Regulatory, Clinical and Precision Medicine, providing investigators with centralized expertise and support for the implementation, coordination and execution of cancer clinical trials. The Cancer Research Informatics Shared Resource Facility supports the CRO through centralized clinical trials management and reporting to the National Cancer Institute (NCI). The CRO staff focuses on MCC's mission, vision and values to support investigators in the highest quality clinical cancer research with adherence to all federal and state guidelines. Part II: Data and Safety Monitoring. All cancer clinical trials conducted by MCC investigators or the MCC Research Network include oversight of data and safety monitoring. The MCC DSMP, approved by the NCI in 2013 and revised annually, provides guidance for the conduct of all cancer clinical trials in accordance with the NCI CCSG requirements. The Data and Safety Monitoring Committee (DSMC) assures patient safety and protocol compliance by MCC investigators and staff, and has monitored 1,654 trials during the reporting period. The QA Office and the Audit Committee perform monitoring and auditing of trials, including 107 trials over the reporting period, as well as assisting in 9 successful external audits. Part III: Inclusion of Women and Minorities in Clinical Research. MCC leadership, investigators and staff are committed to the inclusion of women, all minorities and our National Institutes of Health-designated special population of Central Appalachia in cancer clinical trials. While many trials have genomic, histologic or stage-specific entry criteria, every effort is made toward inclusion, with a focus on clinical trials with high minority incidence such as breast cancer (African-American), hepatocellular carcinoma (Hispanic/Latino, African-American) and prostate cancer (African-American). Females represent over 60% of accruals to treatment interventions and 1,892 women were accrued to interventional protocols in 2016. Part IV: Inclusion of Children in Clinical Research. UK's Pediatric Oncology and Hematology Division has a broad portfolio of trials via the Children's Oncology Group and investigator-initiated trials, spanning common (leukemia/lymphoma, neuroblastoma, Wilms tumor, osteosarcoma) to rare pediatric cancers.

项目摘要/摘要第一部分：临床方案和数据管理（CPDM）。 CPDM促进了所有临床癌症研究 Markey Cancer Center（MCC），负责增加1000多个介入应计。在报告期内年份和9,357次介入应计。 CPDM有3个主要组成部分：临床研究办公室（CRO），质量保证（QA）办公室和MCC数据和安全监控计划（DSMP）。监督由临床翻译副总监，医学博士苏珊·阿诺德（Susanne Arnold）提供（DT），监督CRO医疗总监（MD [DT]）和精密医学中心（PMC）主任（Jill Kolesar，PharmD，MS [DT]），由管理副主任协助（戴维·M·戈斯基（David M. Gosky），马萨诸塞州，MBA）。 CRO由4个运营部门组成：财务，监管，临床和精确医学，为研究人员提供集中的专业知识和对实施的支持，癌症临床试验的协调和执行。癌症研究信息学共享资源设施通过集中的临床试验管理和向国家癌症研究所报告CRO （NCI）。 CRO员工专注于MCC的使命，愿景和价值观，以支持最高的调查员优质临床癌症研究遵守所有联邦和州指南。第二部分：数据和安全监控。 MCC研究者或MCC进行的所有癌症临床试验研究网络包括对数据和安全监控的监督。由NCI批准的MCC DSMP 2013年，每年修订，为所有癌症临床试验的进行指导 NCI CCSG要求。数据和安全监测委员会（DSMC）确保患者安全和 MCC调查人员和工作人员的协议合规性，并在报告期间监视了1,654次试验。质量检查办公室和审计委员会对试验进行监控和审计，包括107次试验报告期，并协助9个成功的外部审核。第三部分：将妇女和少数民族纳入临床研究。 MCC领导，调查人员和员工致力于纳入妇女，所有少数民族和我们的国立卫生研究所癌症临床试验中阿巴拉契亚中部的特殊人群。尽管许多试验具有基因组，组织学或特定于阶段的进入标准，努力全力以赴，重点是临床试验。少数族裔发病率，例如乳腺癌（非裔美国人），肝细胞癌（西班牙裔/拉丁裔，非裔美国人）和前列腺癌（非裔美国人）。女性代表超过60％的应计。 2016年，治疗干预措施和1,892名妇女被纳入介入方案。第四部分：将儿童纳入临床研究。英国的儿科肿瘤学和血液学分类通过儿童肿瘤学小组和研究者发起的试验，拥有广泛的试验组合。常见（白血病/淋巴瘤，神经母细胞瘤，Wilms肿瘤，骨肉瘤）