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 Mays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）以及数据和安全性监查委员会 （DSMC）。CPDM活动由弗吉尼亚·卡克拉马尼（Virginia Kaklamani）医学博士共同领导，D.Sc.，副 临床研究总监和Susan Padalecki博士，研究管理副主任。 两名全职董事Cindy McKeown女士（首席技术官）和Melissa Nashawati女士（QAD）负责监督 中心员工40人。CTO提供中央管理，研究支持和监督功能， 癌症相关的临床试验QAD为制药商发起的研究提供数据监测， 审核方案合规性、数据完整性和患者安全性，并与DSMC密切合作。上述捕捉和模板 大多数情况下是集中的，对管理和预算职能进行全面监督。研究人员使用 权力下放的工作人员遵循相同的方案审查和监测系统（PRMS）准则， 由QAD和DSMC进行审核，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合作，以便能够提供 保护伞监督CTO和QAD为MCC临床疾病研究中心团队提供行政支持 （CDST）、PRMS委员会、DSMC和数据安全和监测委员会（DSMB）。DSMC被指控 监督参与者安全的监测，临床试验的进行，所有数据的有效性和完整性， MCC的癌症相关临床研究。DSMC有权要求方案修订， 安全性，暂停入组或研究活动，并因安全性或数据问题建议关闭研究。超过 在过去的五年中，有7，374名患者参加了MCC的癌症相关临床研究。其中，2，165人 患者入组干预性临床试验，而5，209例患者入组非干预性临床试验 问题研究2018年，186项研究开放招募; 52项（28%）是机构或外部同行评审 研究和74（40%）是NCTN赞助的研究，MCC的最高优先级的研究。共有783名西班牙裔 患者（47%）参加了MCC的临床研究，而所有患者中有979例（59%） 审判是少数民族，反映了我们的大，主要是西班牙裔集水区。之间的分布 2018年MCC新诊断出癌症的男性（52%）和女性（48%）也反映了人口统计学特征。 我们的集水区。MCC还致力于确保癌症儿童有临床试验的机会 通过多项儿童肿瘤学小组（COG）试验并与儿科肿瘤学合作 实验治疗研究者联盟（POETIC），MCC是其创始成员。