Clinical Protocol and Data Management

项目摘要 临床方案和数据管理 临床方案和数据管理（CPDM）为Moffitt癌症中心提供全面支持 （莫菲特）研究人员，促进开发和测试新的治疗方法，预防策略，支持 护理、诊断和生物标志物，将其转化为患者护理。CPDM通过以下方式提供支持 一个有才华的集中团队，负责监督介入和 观察性试验;试验安全性和依从性;数据质量;人员教育;以及适当的 妇女、少数民族和整个生命周期的人。CPDM活动分为四个具体目标： 目标1：支持研究者开发、实施和开展创新的癌症临床研究。 研究，特别强调药物启动试验（IIT） 目标2：通过及时的监控、审计和委员会监督确保安全和合规性 目标3：提供全面的临床研究培训和教育，沿着持续的质量保证， 满足研究数据和研究患者护理的最高标准 目标4：促进妇女、少数群体、整个生命周期的人和其他人适当参与， 临床研究中服务不足的人群 进展包括16，321名患者参与干预性试验，5，716名患者参与治疗性试验， 自上一个报告期以来，试验干预性应计费用总额增加了38%。由于36点 临床研究行动发展计划，2020财政年度的治疗应计费用较2020财政年度增加25%， 2015财年。这些试验的安全性和依从性由方案监测委员会监督， 由CPDM团队根据修订后的NCI批准的数据和安全性监测计划进行协调。 莫菲特一直努力工作，以增加妇女，少数民族，和整个生命周期的人，通过 其少数民族临床研究委员会：1）建立一个委员会，称为达到和从事特别 扩大临床试验的人群; 2）增加少数民族社区的外展和临床试验 研究教育活动;和3）在附属网站建立Moffitt领导的试验。这些努力的结果是 西班牙裔/拉丁裔美国人增加39.3%，干预治疗增加7.8%，非洲裔美国人/黑人增加6.3% 干预性和5.9%的治疗，并计划进一步增加包容性。在报告所述期间， 累积的患者为女性，这与Moffitt观察到的患者相似。Moffitt主要服务于成年患者。 累积时的年龄范围为18 - 94岁（其中52%的人口>65岁），确保个人 参与莫菲特的临床试验。总的来说，CPDM支持成员参与高 通过提供关键的合规性，协调和临床外展服务来影响临床研究 试验生命周期，从方案制定到结束，确保进行严格和创新的 干预性和观察性试验使我们集水区及其他地区的患者受益。

PROJECT SUMMARY CLINICAL PROTOCOL & DATA MANAGEMENT Clinical Protocol & Data Management (CPDM) provides comprehensive support for Moffitt Cancer Center (Moffitt) investigators that facilitate development and testing of new treatments, prevention strategies, supportive care, diagnostics, and biomarkers to translate them to the point of patient care. CPDM provides support through a talented centralized team that oversees the design, development, and conduct of interventional and observational trials; trial safety and compliance; data quality; personnel education; and appropriate accrual of women, minorities, and persons across the lifespan. CPDM activities are organized into four Specific Aims: Aim 1: To support investigators in development, implementation, and conduct of innovative cancer clinical studies, with a particular emphasis on investigator-initiated trials (IITs) Aim 2: To ensure safety and compliance through timely monitoring, audits, and committee oversight Aim 3: To provide comprehensive clinical research training and education, along with ongoing quality assurance, to meet the highest standards of research data and study patient care Aim 4: To facilitate appropriate inclusion of women, minorities, persons across the lifespan, and other underserved populations in clinical research studies Progress has included accruing 16,321 patients to interventional trials and 5,716 to treatment trials, representing a 38% increase in total trial interventional accruals since the previous reporting period. As a result of a 36-point clinical research action development plan, treatment accruals increased by 25% in FY2020 as compared to FY2015. Safety and compliance for these trials is overseen by the Protocol Monitoring Committees and is coordinated by the CPDM team under a revised NCI-approved Data & Safety Monitoring Plan. Moffitt has diligently worked to increase accruals of women, minorities, and persons across the lifespan through its Minority Clinical Research Committee by: 1) establishing a committee called Reaching & Engaging Special Populations to Expand Clinical Trials (RESPECT); 2) increasing minority community outreach and clinical research education events; and 3) establishing Moffitt-led trials at affiliate sites. These efforts resulted in Hispanic/LatinX accrual of 39.3% interventional and 7.8% treatment and African American/Black accrual of 6.3% interventional and 5.9% treatment, with plans to further increase inclusion. During the reporting period, 48% of patients accrued were women, which is similar to patients seen at Moffitt. Moffitt primarily serves adult patients. Age at time of accrual ranged from 18 – 94 (with 52% among being populations >65), ensuring that individuals across the lifespan participate in clinical trials at Moffitt. Overall, CPDM supports Members engaging in high impact clinical research by providing key compliance, coordination, and clinical outreach services throughout the trial lifecycle, from protocol development to closeout, ensuring the conduct of rigorous and innovative interventional and observational trials that benefit patients in our catchment area and beyond.