Mays Cancer Center at UT Health SA

UT Health SA 梅斯癌症中心

• 批准号: 10653965
• 负责人: Virginia Georgia Kaklamani
• 金额: $ 29.3万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10653965
• 关键词: Amendment; Authorization documentation; Cancer Center; Catchment Area; Charge; Child; Clinical Cancer Center; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Conduct Clinical Trials; Data; Decentralization; Development; Disease; Doctor of Medicine; Doctor of Philosophy; Enrollment; Ensure; Goals; Guidelines; Health; Hispanic; Industry; Infrastructure; Institution; Institutional Review Boards; Intervention; Investigational Therapies; Leadership; Malignant Childhood Neoplasm; Malignant Neoplasms; Minority; Monitor; NCI Center for Cancer Research; Newly Diagnosed; Occupations; Patients; Pediatric Oncology; Pediatric Oncology Group; Peer Review; Policies; Procedures; Protocol Compliance; Protocols documentation; Quality Control; Recommendation; Regulation; Reporting; Research; Research Personnel; Research Support; Safety; Site; System; Time; Training; Training Activity; Training and Education; Virginia; Woman; Work; authority; clinical trial protocol; data integrity; data management; data quality; demographics; member; men; operation; participant safety; patient safety; quality assurance; research study; safety study

Project Summary--Clinical Protocol and Data Management The Clinical Protocol and Data Management (CPDM) component of the Mays Cancer Center (MCC) includes the Clinical Trials Office (CTO), Quality Assurance Division (QAD), and Data and Safety Monitoring Committee (DSMC). CPDM activities are overseen by the shared leadership of Virginia Kaklamani, M.D., D.Sc., Associate Director for Clinical Research and Susan Padalecki, Ph.D., Associate Director for Research Administration. Two full-time Directors, Ms. Cindy McKeown (CTO) and Ms. Melissa Nashawati (QAD), supervise a centralized staff of 40. The CTO provides central management, research support, and oversight functions for cancer-related clinical trials at the MCC. The QAD provides data monitoring for investigator-initiated studies, auditing for protocol compliance, data integrity and patient safety and works closely with the DSMC. The CTO is mostly centralized, providing overall oversight of regulatory and budgetary functions. Researchers who use decentralized staff follow the same Protocol Review and Monitoring System (PRMS) guidelines, are subject to audit by QAD and the DSMC, and use a centralized CTMS, have the same job functions, participate in CTO training, follow CTO standard operating procedures (SOPs) and work in concert with CTO so that it can provide umbrella oversight. The CTO and QAD provide administrative support for the MCC Clinical Disease Site Teams (CDSTs), PRMS committees, DSMC, and the Data Safety and Monitoring Board (DSMB). The DSMC is charged with overseeing monitoring of participant safety, conduct of clinical trials, the validity and integrity of data for all cancer-related clinical studies at the MCC. The DSMC has the authority to require protocol amendments for safety, suspend enrollment or study activities and recommend closure of studies for safety or data issues. Over the past five years, 7,374 patients were enrolled in cancer-related clinical studies at the MCC. Of those, 2,165 patients were accrued to interventional clinical trials, while 5,209 patients were enrolled on non-interventional studies. In 2018, 186 studies were open to accrual; 52 (28%) were institutional or externally peer-reviewed studies and 74 (40%) were NCTN-sponsored studies, the MCC’s highest-priority studies. A total of 783 Hispanic patients (47%) were enrolled in clinical research studies at the MCC, while 979 (59%) of all patients placed on trial were minorities, reflecting our large and predominantly Hispanic catchment area. The distribution between men (52%) and women (48%) newly diagnosed with cancer at MCC in 2018 also reflects the demographics of our catchment area. The MCC also works to ensure children with cancer have clinical trial opportunities through multiple Children’s Oncology Group (COG) trials and in collaboration with the Pediatric Oncology Experimental Therapeutic Investigators Consortium (POETIC), for which MCC is a founding member.

项目总结--临床方案和数据管理 梅斯癌症中心(MCC)的临床方案和数据管理(CPDM)部分包括 临床试验办公室(CTO)、质量保证司(QAD)以及数据和安全监测委员会 (Dsmc)。CPDM活动由Viria Kaklamani，M.D.，D.Sc，Associate的共同领导层监督 临床研究主任Susan Padalecki博士和研究管理副主任Susan Padalecki博士。 两位全职董事Cindy McKeown女士(首席技术官)和Melissa Nashawati女士(QAD)监督 集中管理40名员工。CTO提供集中管理、研究支持和监督职能 在MCC进行的癌症相关临床试验。QAD为研究人员发起的研究提供数据监控， 审核协议合规性、数据完整性和患者安全，并与DSMC密切合作。首席技术官是 大部分是集中的，提供对监管和预算职能的全面监督。研究人员使用 分散的工作人员遵循相同的议定书审查和监测系统(PRMS)指导方针，须遵守 由QAD和DSMC审核，并使用集中的CTMS，具有相同的工作职能，参与CTO 培训，遵循CTO标准操作程序(SOP)，并与CTO协同工作，以便它能够提供 保护伞监督。CTO和QAD为MCC临床疾病现场团队提供行政支持 数据安全和监测委员会(CDSTS)、PRMS委员会、数据安全和监测委员会(DSMB)。对dsmc进行收费 监督参与者的安全性、临床试验的进行、数据的有效性和完整性 MCC与癌症相关的临床研究。Dsmc有权要求修改以下内容的协议 安全，暂停招生或学习活动，并建议因安全或数据问题关闭研究。完毕 在过去的五年里，MCC有7374名患者参加了与癌症相关的临床研究。其中，2165人 患者参加干预性临床试验，5209名患者参加非干预性临床试验 学习。在2018年，186项研究可以应计；52项(28%)是机构或外部同行审查的 研究和74项(40%)由NCTN赞助的研究，是MCC最优先的研究。总计783名西班牙裔美国人 患者(47%)参加了MCC的临床研究，而所有患者中有979人(59%)被置于 受审的是少数族裔，这反映了我们以西班牙裔为主的广阔集水区。两国之间的分配 2018年MCC新诊断出癌症的男性(52%)和女性(48%)也反映了人口统计数据 我们的集水区。MCC还致力于确保癌症儿童有临床试验机会 通过多个儿童肿瘤学小组(COG)试验并与儿科肿瘤学合作 实验治疗研究联盟(POITIC)，MCC是其创始成员。