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的临床和人口科学试验的职能 服务于集水区的临床站点。数据安全和监测委员会（DSMC）提供了一个强大的 审核UCCC合作研究中心临床试验的结构。DSMC的监督优先考虑高风险 第一阶段和第二阶段方案。成就：自2016年以来，CPDM大大改善了临床 研究支持如下：1）研究者发起的试验（IIT）支持导致IIT应计费用增加411% 2017-2020年与之前2013-2016年类似时期相比; 2）肿瘤临床研究的发展 研究支助小组。OCRST提供集中的SOP开发、工作人员和研究者 培训、多中心协调和简化流程，以成功实施临床 3）扩大前沿临床试验网络（FRCTN） 为科罗拉多的人们提供临床试验的机会。纳入5 UCHealth系统临床研究 FRCTN中的站点为临床和人群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农村/城市混合的多样性; UCHealth在整个UCHealth系统中实施了Via Oncology Pathways，并将临床试验内置到 途径，以确保在整个集水区的认识和获得UCCC临床试验。质量控制 和培训：CPDM启动了一个教育课程，以提供一个连贯和相关的培训， 结构，以新的工作人员和教师和正在进行的教育，以确保那些参与进行临床 调查人员了解政策和条例。开发了一种新的课程， UCCC，UCAMC，科罗拉多临床和转化科学研究所内的教育资源 （CCTSI，UL 1 TR 001082），并通过从试验稽查中收到的反馈进行增强。试验区和集水区 人口统计学：CPDM每年平均监督527项临床研究。2020财年，608 将患者纳入干预治疗研究。在UCCC看到的病人来自所有64个科罗拉多 个县根据2020年的数据，患者应计费用与国家癌症人口统计数据一致。UCCC 有一个计划，以增加西班牙裔登记至少10%，并提高临床试验的人口访问， 大.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.