Clinical Protocol and Data Management

临床方案和数据管理项目总结 马约诊所癌症中心（MCCC）临床方案和数据管理（CPDM）职能包括 由MCCC临床研究委员会（由MCCC副主任主持）进行行政监督 临床研究），并由MCCC临床研究办公室（CRO）进行职能协调， 安全性监查委员会（DSMC）和数据和安全性监查委员会（DSMB）。CPDM 其职能包括临床研究操作和数据质量监控，由医学总监负责 和行政总监，并得到CRO工作人员的支持。CRO执行开发、激活、 研究维护、研究协调、管理和报告在以下地点进行的所有癌症临床试验 MCCC。此外，合同研究组织还为方案审查和监测系统提供业务支持 （PRMS）和数据和安全监测（DSM）系统。MCCC的CPDM和DSM功能是 与PRMS职能不同，成员略有重叠。CRO的工作人员与 MCCC临床研究者在整个临床研究中提供专家，有效的支持 企业和个别疾病组，以确保有效的开发和启动临床试验 符合MCCC计划的优先事项。 在过去的资助期内，CRO监督了617项研究的开发和启动，包括一项 越来越复杂的研究组合（例如，检查点抑制剂、CAR T细胞、篮式和伞式试验 有针对性的治疗）。它根据疾病组的增长提供了人员支助， 根据疾病组增长战略，促进了各种试验的开展，并保持了 过去3年稳定的临床试验累积量。随着综合早期癌症的建立， 随着细胞治疗疾病组的发展，CRO继续发展 有效支持新颖、复杂和创新的试验。在改善 临床试验启动流程，以解决效率、启动时间和质量问题。目前的事态发展将 包括实施新的临床研究管理系统。 MCCC通过中心的DSM系统对参与者的安全进行监督，其职能由 DSMC和DSMB。DSMC广泛关注安全性，而不是单个研究。它评估 方案偏离和毒性的趋势，并建议MCCC范围内的程序变更， 确保研究按照MCCC的数据安全和监测计划进行， 联邦、地方和机构政策。DSMC还每年审查DSM计划，并监督 DSMB功能。DSMB将审查重点放在个别研究上，通过定期审查来确保患者安全性。 审查研究中的不良事件和个体试验对研究干预的反应。

CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY The Mayo Clinic Cancer Center (MCCC) Clinical Protocol and Data Management (CPDM) functions are administratively overseen by the MCCC Clinical Research Committee (Chaired by the MCCC Deputy Director for Clinical Research) and functionally coordinated by the MCCC Clinical Research Office (CRO), the Data and Safety Monitoring Committee (DSMC), and the Data and Safety Monitoring Board (DSMB). The CPDM functions include clinical research operations and data quality monitoring, facilitated by the Medical Director and Administrative Director and supported by the CRO staff. The CRO carries out development, activation, study maintenance, study coordination, administration, and reporting for all cancer clinical trials conducted at the MCCC. In addition, the CRO provides operational support for the Protocol Review and Monitoring System (PRMS) and the Data and Safety Monitoring (DSM) System. The CPDM and DSM functions at MCCC are distinct from PRMS functions, with minor overlap of membership. Staff in the CRO work collaboratively with the MCCC clinical investigators to provide expert, efficient support in the conduct of clinical research across the enterprise and with individual Disease Groups to ensure efficient development and activation of clinical trials consistent with the priorities of the MCCC Programs. Over the past grant period, the CRO has overseen the development and activation of 617 studies, including an increasingly complex portfolio of studies (e.g., checkpoint inhibitors, CAR T-cells, basket and umbrella trials with targeted therapies). It has provided staffing support in alignment with the growth of the Disease Groups, facilitated the opening of a wide variety of trials in line with Disease Group growth strategies, and maintained stable clinical trial accrual volumes over the last 3 years. With the creation of the integrated Early Cancer Therapeutics (ECTx) unit and the growth of the Cellular Therapy Disease Group, the CRO continues to evolve to efficiently support novel, complex, and innovative trials. Significant progress has been made to improve the clinical trial activation process to address efficiency, time to activation, and quality. Ongoing developments will include the implementation of a new clinical research management system. MCCC provides oversight for participant safety through the Center's DSM system, with functions carried out by the DSMC and the DSMB. The DSMC focuses broadly on safety rather than on individual studies. It evaluates trends in protocol deviations and toxicities and recommends MCCC-wide procedural changes aimed at ensuring that studies are conducted in accordance with MCCC's Data Safety and Monitoring Plan and with federal, local, and institutional policies. The DSMC also reviews the DSM Plan annually and oversees the DSMB functions. The DSMB focuses their review on individual studies, ensuring patient safety by regularly reviewing adverse events on study and responses to the study intervention for individual trials.