Clinical Protocol and Data Management

临床方案和数据管理：摘要 佛罗里达大学癌症健康中心的临床方案和数据管理(CPDM)部分 UFHCC中心为有效开展临床癌症提供全面的资源和质量控制 与我们的集水区(CA)相关的研究，包括针对少数群体、妇女和个人的努力 在整个生命周期内。CPDM由临床研究副主任George(CTHR)负责监督，以及 由UFHCC临床研究办公室(CRO)实施。UFCC领导和员工为临床提供支持 解决UFCC CA需求的研究，重点是获得由以下方面产生的新疗法 UFHCC研究计划。CRO通过以下方式促进高质量临床研究的高效进行 集中管理、报告和质量保证功能。CRO为UFCC调查人员提供 基础设施，用于管理各种由研究者发起的试验(IIT)、外部同行评审、NCI赞助、 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 通过支持协议制定、激活、法规遵从性、参与者筛选来支持UFCC成员 以及招聘、研究药房互动、临床研究协调、数据提取、 信息传播，以及与赞助商和监管机构的互动。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 UFCC数据和安全监控计划，描述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。UFCC 研究组合强调IITs、NCI赞助的研究和其他专注于以下方面的早期治疗试验 难治性疾病，以解决我们CA中不成比例的晚期癌症诊断数量。从… 2016年至2021年，活跃的UFCC IITs数量从24个增加到39个，增长了63%，而活跃的 所有类型的干预方案，特别是治疗、筛查和支持性护理，增加了19% 从162降到192。与UFCC支持NCI赞助试验的优先事项一致，UF现在是投票的主要对象 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，UFCC累积了515名介入性癌症参与者- 相关临床试验，其中70%的参与者参加了IITs(23%参加了治疗IITs)。增加了 强调介入方案和更有效的患者筛查，逐年增加 招生是在大流行之前进行的。2021年，有1748人(自2016年以来增长了3.4倍)进行了干预 应计项目(UFCC IITs的91%)，包括299项治疗应计项目(自2016年以来增长2.2倍；IITs的59%)。而当 UFCC预计，由于新冠肺炎在佛罗里达州的显著影响，治疗应计费用较少 通过扩大临床试验组合、增强参与者筛选来恢复治疗应计费用 资源，并加强了与社区外联和参与办公室的协作。

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.