Mays Cancer Center at UT Health SA

UT Health SA 梅斯癌症中心

• 批准号: 10460446
• 负责人: Michael Andre Liss
• 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/10460446
• 关键词: Amendment; Cancer Center; Catchment Area; Charge; Clinical Cancer Center; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical trial protocol document; Collaborations; Conduct Clinical Trials; Data; Decentralization; Development; Disease; Doctor of Medicine; Doctor of Philosophy; Enrollment; Ensure; Goals; Guidelines; Health; Hispanic; Industry; Infrastructure; Institutional Review Boards; Intervention; Investigational Therapies; Leadership; Malignant Childhood Neoplasm; Malignant Neoplasms; Melissa; 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; Regulation; Reporting; Research; Research Personnel; Research Support; Safety; Site; Supervision; System; Time; Training; Training Activity; Training and Education; Virginia; Woman; Work; authority; data integrity; data management; data quality; demographics; member; men; minority children; 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)、质量保证部 (QAD) 以及数据和安全监测委员会 (DSMC) CPDM 活动由弗吉尼亚·卡克拉玛尼 (Virginia Kaklamani)（医学博士、理学博士、助理）共同领导。 临床研究总监和研究管理副总监 Susan Padalecki 博士。 两位全职董事 Cindy McKeown 女士（CTO）和 Melissa Nashawati 女士（QAD）负责监督 集中管理人员 40 人。CTO 提供中央管理、研究支持和监督职能 MCC 的癌症相关临床试验为研究者发起的研究提供数据监测， CTO 负责对方案合规性、数据完整性和患者安全进行审核，并与 DSMC 密切合作。 主要是集中化的，对使用的研究人员进行总体监督。 分散的工作人员遵循相同的协议审查和监测系统（PRMS）指南，并受到 由QAD和DSMC审核，并使用集中式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，以便能够提供 CTO 和 QAD 为 MCC 临床疾病现场团队提供行政支持。 (CDST)、PRMS 委员会、DSMC 以及数据安全和监控委员会 (DSMB)。 监督参与者的安全、临床试验的进行、所有人数据的有效性和完整性 MCC 的癌症相关临床研究有权要求修改方案。 安全，暂停招募或研究活动，并因安全或数据问题建议结束研究。 过去五年，MCC 招募了 7,374 名患者参加癌症相关临床研究，其中 2,165 名患者。 共有 5,209 名患者参加了介入性临床试验，而 5,209 名患者则参加了非介入性临床试验 2018 年，有 186 项研究可供应计；其中 52 项（28%）经过机构或外部同行评审。 其中 74 项 (40%) 是 NCTN 赞助的研究，这是 MCC 的最高优先级研究。总共 783 项西班牙裔研究。 患者 (47%) 参加了 MCC 的临床研究，而所有患者中有 979 名 (59%) 接受了 试验是少数族裔，反映了我们庞大且以西班牙裔为主的学区之间的分布。 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 MCC 还致力于确保癌症儿童获得临床试验机会。 通过多项儿童肿瘤学组 (COG) 试验并与儿科肿瘤学合作 实验治疗研究者联盟 (POETIC)，MCC 是该联盟的创始成员。