Clinical Protocol and Data Management

摘要 概述：临床方案和数据管理(CPDM)提供集中管理和监督 协调、促进和报告UCCC临床和人口科学试验的职能 为集水区提供服务的诊所地点。数据安全和监控委员会(DSMC)提供强大的 在UCCC合作伙伴网站上审核临床试验的结构。DSMC的监管优先考虑高风险 第一阶段和第二阶段协议。成就：自2016年以来，CPDM显著改善了临床 研究支持如下：1)调查员发起的试验(IIT)支持导致IIT应计项目增加411% 2017-2020年与2013-2016年同期比较；2)肿瘤学临床发展 研究支持团队(OCRST)。OCRST提供集中的SOP开发、工作人员和调查人员 培训、多地点协调和简化流程，以成功实施临床 网络中的研究协议；3)扩大前沿临床试验网络(FRCTN) 为科罗拉多州的居民提供临床试验机会。纳入加州大学健康系统的5项临床研究 鉴于FRCTN的规模，FRCTN的站点为临床和人口健康研究提供了巨大的机会 人口的社会经济人口结构及其城乡比例的多样性；4)CPDM和 UCHealth在整个UCHealth系统中实施了VIA肿瘤学路径，并将临床试验内置到 确保了解和获得整个集水区UCCC临床试验的途径。质量控制 和培训：CPDM启动了一项教育课程，以提供有凝聚力和相关性的培训 对新员工和教职员工的结构和持续教育，以确保那些参与临床工作的人 调查人员仍然了解政策和法规。开发了一门新的课程，它利用 UCCC、UCAMC、科罗拉多州临床和转化科学研究所内的教育资源 (CCTSI，UL1TR001082)，并得到从试验审计中收到的反馈的加强。试验和集水区 人口统计：CPDM每年平均监督527项临床研究。2020财年，608 患者被累积到干预治疗研究中。在加州大学旧金山分校看到的患者来自科罗拉多州的 各县。根据2020年的数据，患者的应计收入与该州的癌症人口统计数据一致。UCCC 有一项计划将西班牙裔登记人数增加到至少10%，并改善在 大号的。综上所述，这些数据表明CPDM取得了实质性进展，并进一步表明 UCCC对癌症患者的承诺。

ABSTRACT Overview: The Clinical Protocol and Data Management (CPDM) provides central administration and oversight functions for coordinating, facilitating, and reporting on clinical and population sciences trials across the UCCC clinical sites serving the catchment. The Data Safety and Monitoring Committee (DSMC) provides a robust structure for auditing clinical trials across the UCCC partner sites. DSMC's oversight is prioritized for high-risk Phase I and Phase II protocols. Accomplishments: Since 2016, the CPDM substantially improved clinical research support as follows: 1) Investigator-initiated trial (IIT) support leading to a 411% increase in IIT accruals from 2017-2020 compared to the previous similar period of 2013-2016; 2) Development of the Oncology Clinical Research Support Team (OCRST). OCRST provides centralized SOP development, staff and investigator training, multi-site coordination, and streamlining of processes for the successful implementation of clinical research protocols across the network; 3) Expansion of the Front Range Clinical Trials Network (FRCTN) provides clinical trial access to the population of Colorado. The inclusion of 5 UCHealth System clinical research sites in the FRCTN presents an enormous opportunity for clinical and population health research given the size and diversity of the socioeconomic demographics of the population and its rural/urban mix; 4) CPDM and UCHealth implemented the Via Oncology Pathways across the UCHealth system with clinical trials built into the pathways to ensure awareness and access to UCCC clinical trials across the catchment area. Quality Control and Training: The CPDM initiated an educational curriculum to provide a cohesive and relevant training structure to new staff and faculty and ongoing education to ensure those involved in the conduct of clinical investigation remain knowledgeable of policies and regulations. A new curriculum was developed that utilizes educational resources within the UCCC, UCAMC, the Colorado Clinical and Translational Sciences Institute (CCTSI, UL1TR001082) and enhanced by feedback received from trial audits. Trials and Catchment Area Demographics: The CPDM oversees an annual average of 527 clinical research studies. In FY2020, 608 patients were accrued to intervention-treatment studies. Patients seen at UCCC come from all 64 Colorado counties. Based on data from 2020, patient accruals were consistent with the state cancer demographics. UCCC has a plan to increase Hispanic enrollment to at least 10% and improve clinical trial access to the population at large. Taken together, these data demonstrate substantial progress in the CPDM and further demonstrate the UCCC's commitment to patients with cancer.