Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10625762
• 负责人: Thomas J. George
• 金额: $ 16.95万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10625762
• 关键词: Abbreviations; Address; Advanced Malignant Neoplasm; Adverse event; Biometry; COVID-19 impact; Cancer Center; Cancer Center Support Grant; Cancer Control; Cancer Intervention; Catchment Area; Clinical; Clinical Cancer Center; Clinical Data; Clinical Investigator; Clinical Management; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials; Clinical Trials Network; Collaborations; Community Outreach; Computerized Medical Record; Data; Disease; Early Therapeutic-Clinical Trials Network; Electronics; Enrollment; Ensure; Florida; Health; Immune response; Individual; Industry; Information Dissemination; Infrastructure; Institution; Intervention; Investigational Therapies; Last Name; Lead; Leadership; Longevity; Malignant Neoplasms; Methodological Studies; Minority; Monitor; NCI Center for Cancer Research; Oncology; Participant; Patients; Pediatric Oncology Group; Peer Review; Pharmaceutical Services; Pharmacy facility; Phase; Population; Population Sciences; Principal Investigator; Procedures; Protocols documentation; Quality Control; Recovery; Refractory Disease; Regulatory Affairs; Reporting; Research; Research Activity; Research Design; Research Personnel; Resource Sharing; Resources; Safety; Science; Site; Specific qualifier value; Strategic Planning; Structure; Supportive care; System; Text; Training Activity; Training and Education; Translations; Underrepresented Minority; Underserved Population; Universities; University adminstration; Voting; Woman; anticancer research; cancer diagnosis; clinical trial protocol; clinically relevant; community engagement; data integrity; data management; investigator-initiated trial; member; novel therapeutics; pandemic disease; participant enrollment; participant safety; patient screening; pre-clinical; programs; protocol development; quality assurance; recruit; research study; screening; sound; success; treatment response; treatment trial

CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT The Clinical Protocol and Data Management (CPDM) component of the University of Florida Health Cancer Center (UFHCC) provides comprehensive resources and quality control for the efficient conduct of clinical cancer research relevant to our catchment area (CA), inclusive of efforts to address minorities, women, and individuals across the lifespan. The CPDM is overseen by George (CTHR), Associate Director for Clinical Research, and implemented by the UFHCC Clinical Research Office (CRO). UFHCC leadership and staff support clinical research addressing the needs of the UFHCC CA, with an emphasis on access to novel therapies arising from UFHCC research programs. The CRO facilitates the efficient conduct of high-quality clinical research through centralized management, reporting, and quality assurance functions. The CRO offers UFHCC investigators the infrastructure to manage a full range of investigator-initiated trials (IITs), external peer-reviewed, NCI sponsored, and industry trials, while also facilitating and tracking non-interventional studies. The CRO meets the needs of UFHCC members by supporting protocol development, activation, regulatory compliance, participant screening and recruitment, investigational pharmacy interactions, clinical research coordination, data abstraction, information dissemination, and interactions with sponsors and regulatory bodies. The CRO also provides centralized education and training to augment data integrity and participant safety. The office administers the UFHCC Data and Safety Monitoring Plan that delineates the structure and responsibilities of the Data Integrity and Safety Committee which reviews and assures the safe conduct of UFHCC clinical research. The UFHCC research portfolio emphasizes IITs, NCI sponsored studies, and other early phase treatment trials focusing on refractory diseases, to address the disproportionate number of advanced cancer diagnoses in our CA. From 2016 to 2021, the number of active UFHCC IITs increased by 63% from 24 to 39 while the number of actively accruing interventional protocols of all types, particularly treatment, screening, and supportive care, rose by 19% from 162 to 192. Consistent with UFHCC priorities to support NCI sponsored trials, UF is now a voting main member of NRG Oncology, a full member of the Children's Oncology Group, and currently the only non-NCI- Designated center member of the ETCTN. In 2016, UFHCC accrued 515 participants to interventional cancer- relevant clinical trials with 70% of those participants enrolling to IITs (23% on treatment IITs). With an increased emphasis on interventional protocols and more effective patient screening, year over year increases in enrollment occurred leading up to the pandemic. In 2021, there were 1,748 (up 3.4-fold since 2016) interventional accruals (91% on UFHCC IITs), including 299 treatment accruals (up 2.2-fold since 2016; 59% on IITs). While there were fewer treatment accruals due to the significant impact of COVID-19 in Florida, the UFHCC anticipates recovery of treatment accruals with expansion of the clinical trial portfolio, enhanced participant screening resources, and strengthened collaboration with the Office of Community Outreach and Engagement.

临床方案和数据管理：摘要 佛罗里达健康癌症大学的临床方案和数据管理（CPDM）部分 中心（UFHCC）提供全面的资源和质量控制，为临床癌症的有效进行 与我们的集水区（CA）相关的研究，包括解决少数民族，妇女和个人问题的努力 在整个生命周期中。CPDM由临床研究副总监乔治（CTHR）监督， 由UFHCC临床研究办公室（CRO）实施。UFHCC领导层和工作人员支持临床 研究解决UFHCC CA的需求，重点是获得新的治疗方法， UFHCC研究计划。CRO通过以下方式促进高质量临床研究的有效开展： 集中管理、报告和质量保证职能。CRO为UFHCC研究者提供 基础设施，以管理全方位的制药商发起的试验（IIT），外部同行评审，NCI申办， 和行业试验，同时也促进和跟踪非干预性研究。CRO满足以下需求： UFHCC成员通过支持方案制定、激活、法规遵从性、参与者筛选 和招募，研究药物相互作用，临床研究协调，数据提取， 信息传播以及与申办者和监管机构的互动。CRO还提供 集中教育和培训，以增强数据完整性和参与者安全。该办公室负责管理 UFHCC数据和安全性监测计划，描述了数据完整性的结构和职责 和安全委员会，负责审查和确保UFHCC临床研究的安全进行。UFHCC 研究组合强调IIT、NCI赞助的研究和其他早期治疗试验，重点是 难治性疾病，以解决我们CA中晚期癌症诊断的不成比例的数量。从 2016年至2021年，UFHCC IIT的活跃数量从24个增加到39个，增加了63%，而活跃的UFHCC IIT数量则从24个增加到39个。 所有类型的介入治疗，特别是治疗、筛查和支持性护理，增加了19% 从162到192与UFHCC支持NCI申办试验的优先事项一致，UF现在是一个投票主体 NRG肿瘤学的成员，儿童肿瘤学小组的正式成员，目前唯一的非NCI- ETCTN的指定中心成员。2016年，UFHCC累计515名参与者参与了介入性癌症- 相关临床试验，70%的参与者入组IIT（23%接受治疗IIT）。具有增加的 强调介入方案和更有效的患者筛查， 在大流行病爆发之前就有招募。2021年，共有1，748例（自2016年以来增长3.4倍）介入性 应计费用（UFHCC IIT为91%），包括299项治疗应计费用（自2016年以来增长2.2倍; IIT为59%）。而 UFHCC预计，由于COVID-19对佛罗里达的重大影响， 随着临床试验组合的扩大，受试者筛选的加强， 资源，并加强与社区外展和参与办公室的合作。