Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10629291
• 负责人: Amitkumar N Mehta
• 金额: $ 38.97万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-28 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10629291
• 关键词: Abbreviations; Administrative Supplement; Adolescent and Young Adult; Aging; Alabama; Award; Cancer Biology; Cancer Burden; Cancer Center Support Grant; Cancer Control; Cancer Intervention; Cancer Patient; Catchment Area; Classification; Clinical; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Community Outreach; Comprehensive Cancer Center; Data; Data Reporting; Dedications; Development; Disease; Early Therapeutic-Clinical Trials Network; Education; Elements; Ensure; Fostering; Health system; Incidence; Infrastructure; Institution; Institutional Review Boards; Intervention; Intervention Trial; Investigational Therapies; Leadership; Letters; Longevity; Maintenance; Malignant Neoplasms; Mentors; Mentorship; Minority; Minority Participation; Monitor; Occupational activity of managing finances; Participant; Patient Recruitments; Patients; Persons; Population; Population Sciences; Procedures; Process; Protocols documentation; Regulation; Reporting; Research Activity; Research Personnel; Resources; Review Committee; Risk; Safety; Services; Site; System; Time; Training; Training and Education; Underserved Population; Universities; Woman; anticancer research; cancer care; cancer clinical trial; cancer therapy; clinical investigation; clinical trial participant; community engagement; data integrity; data management; data quality; design; ethnic minority; high standard; improved; investigator-initiated trial; member; neuro-oncology; participant safety; patient safety; programs; protocol development; quality assurance; racial minority; treatment trial; tumor immunology; working group

ABSTRACT - CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) The Clinical Protocol and Data Management (CPDM) of the O'Neal Comprehensive Cancer Center (O'Neal) maintains the highest standards of clinical investigation that are aligned with all university, state, and federal regulations, while assisting investigators in protocol development and all aspects related to clinical investigation. The CPDM is responsible for the following significant functions: 1) coordination, tracking, and reporting of all cancer clinical research activity undertaken at O'Neal, 2) continuous improvement of the clinical trial activation process, 3) ongoing education and training of clinicians and clinical research staff, 4) clinical trial data quality monitoring, 5) cancer clinical trial participant safety, and 6) actively ensuring all sections of the population represented in the O'Neal catchment area have the opportunity to be represented in cancer clinical trials. The O'Neal Clinical Trials Office (CTO) supports cancer treatment trials by providing regulatory services, financial management, recruitment of participants, clinical coordination, and data management. The CTO houses a specialized investigator-initiated trial (IIT) support team focused on protocol development, multi-site coordination, project management, and sponsor-level interactions with regulatory agencies. During the current CCSG cycle, there was an early decline in clinical trial activity. With establishment of new leadership in 2020 multiple interventions were put in place to increase overall accrual to treatment trials, foster the development of IITs, reduce overall time to protocol activation, and guide clinical trial activities to fit the cancer burden in Alabama. There were 12,861 accruals to interventional trials, including 2,261 accruals to treatment trials in the period, with a 13% increase in yearly accrual to treatment trials in 2020 when compared to 2019, in an upward trajectory that continues in 2021. The Data and Safety Monitoring Committee (DSMC) provides independent oversight of all clinical trials sponsored by O'Neal investigators to ensure safety of participants and integrity of data generated. The DSMC employs a risk-based classification of trials matched with different levels and scopes of audits and data review. During the current CCSG cycle, the DSMC oversaw an average of 88 trials at any given time, and performed 43 full audits/year. In coordination with our Office of Community Outreach and Engagement (OCOE), we have expanded efforts towards increased representation of women and racial-ethnical minorities in O'Neal trials. In the current CCSG cycle, 57% of participants in O'Neal treatment trials were women, and 21% were minorities. Efforts to increase minority participation include the maintenance of a lay navigator clinical trial facilitation program, award of a CATCH-UP 2020 ETCTN administrative supplement, and establishment of strategic collaboration with health systems serving under-resourced populations. We maintain a strong commitment to expanding cancer clinical research to all patients across the lifespan with establishment of a Cancer and Aging program and an Adolescent and Young Adult Cancer program.

摘要 - 临床方案和数据管理 (CPDM) 奥尼尔综合癌症中心（O'Neal）的临床方案和数据管理（CPDM） 保持与所有大学、州和联邦一致的最高临床研究标准 法规，同时协助研究人员制定方案以及与临床研究相关的所有方面。 CPDM 负责以下重要职能： 1) 协调、跟踪和报告所有 奥尼尔开展的癌症临床研究活动，2) 临床试验激活的持续改进 流程，3) 临床医生和临床研究人员的持续教育和培训，4) 临床试验数据质量 监测，5) 癌症临床试验参与者的安全，以及 6) 积极确保各阶层人群的安全 奥尼尔流域的代表有机会代表参加癌症临床试验。这 奥尼尔临床试验办公室 (CTO) 通过提供监管服务、财务支持来支持癌症治疗试验 管理、参与者招募、临床协调和数据管理。 CTO 拥有一个 专业研究者发起的试验 (IIT) 支持团队专注于方案开发、多中心协调、 项目管理以及赞助商层面与监管机构的互动。在当前的 CCSG 周期内， 临床试验活动早期出现下降。随着 2020 年新领导层的成立， 采取干预措施以增加治疗试验的总体收益，促进 IIT 的发展， 缩短方案激活的总时间，并指导临床试验活动以适应阿拉巴马州的癌症负担。 在此期间，干预试验有 12,861 项应计项目，其中治疗试验有 2,261 项应计项目， 与 2019 年相比，2020 年治疗试验的年度应计增加了 13%，呈上升趋势 2021 年继续。数据和安全监测委员会 (DSMC) 对所有 由奥尼尔研究人员赞助的临床试验，以确保参与者的安全和生成数据的完整性。 DSMC 采用基于风险的试验分类，与不同级别和范围的审核相匹配 数据审查。在当前的 CCSG 周期中，DSMC 在任何给定时间平均监督了 88 次试验，并且 每年进行 43 次全面审核。与我们的社区外展和参与办公室 (OCOE) 协调， 我们加大了努力，以增加奥尼尔中女性和少数族裔的代表性 试验。在当前的 CCSG 周期中，奥尼尔治疗试验的参与者中有 57% 是女性，21% 是女性 少数民族。增加少数族裔参与的努力包括维持非专业导航临床试验 促进计划、授予 CATCH-UP 2020 ETCTN 行政补充以及建立 与为资源贫乏人群服务的卫生系统进行战略合作。我们保持着强大的 致力于将癌症临床研究扩展到整个生命周期的所有患者，建立一个 癌症与衰老计划以及青少年和年轻人癌症计划。