Clinical Protocol and Data Management

项目总结 临床方案和数据管理 临床方案和数据管理(CPDM)为莫菲特癌症中心提供全面支持 (Moffitt)促进开发和测试新治疗方法、预防策略、支持性 护理、诊断和生物标记物，以将它们转化为患者护理的要点。CPDM通过以下方式提供支持 一支才华横溢的集中式团队，负责监督干预性和 观察性试验；试验的安全性和遵从性；数据质量；人员教育； 妇女、少数族裔和人的一生。CPDM活动被组织成四个具体目标： 目标1：支持研究人员开发、实施和实施创新的癌症临床 研究，特别强调由调查员发起的试验(IITs) 目标2：通过及时监测、审计和委员会监督，确保安全和合规 目标3：提供全面的临床研究培训和教育，以及持续的质量保证， 达到最高标准的研究数据和研究病人护理 目标4：促进妇女、少数群体、整个生命周期的人以及其他人的适当融入 临床研究中服务不足的人群 进展包括：16321名患者参加介入试验，5716名患者参加治疗试验， 自上一个报告期以来，试验干预应计费用总额增加了38%。作为36点的结果 临床研究行动发展计划，2020财年治疗应计收入比 2015财年。这些试验的安全性和合规性由礼宾监测委员会监督，并由 由CPDM团队根据修订的NCI批准的数据和安全监控计划进行协调。 莫菲特勤奋地工作，通过以下方式增加妇女、少数族裔和个人的终生收益 其少数族裔临床研究委员会通过：1)建立一个名为REACHING&INGING Special的委员会 人口扩大临床试验(REPORT)；2)增加少数族裔社区的推广和临床 研究教育活动；以及3)在附属网站建立莫菲特领导的试验。这些努力导致了 西班牙裔/拉丁裔占39.3%，介入治疗占7.8%，非裔美国人/黑人占6.3% 介入治疗和5.9%的治疗，并计划进一步增加纳入。在本报告所述期间，48% 累积的患者是女性，这与在莫菲特看到的患者类似。莫菲特主要为成人患者服务。 计提时的年龄从18岁到94岁(其中52%在人口中)，确保个人 在整个生命周期中，参与莫菲特的临床试验。总体而言，CPDM支持会员从事高 通过在整个过程中提供关键的合规、协调和临床推广服务来影响临床研究 试验生命周期，从协议制定到结束，确保进行严谨和创新 干预性和观察性试验，使我们集水区和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.