Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9904171
• 负责人: Aaron Thomas Gerds
• 金额: $ 59.96万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9904171
• 关键词: Address; Age; Biopsy; Budgets; Cancer Center Support Grant; Cancer Patient; Cancer Survivor; Child; Clinical Data; Clinical Investigator; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Unit; Comprehensive Cancer Center; Conduct Clinical Trials; Contracts; Data; Databases; Development; Diagnosis; Education; Enrollment; Ensure; Ethnic Origin; Gender; Goals; Healthcare Systems; Infrastructure; Institution; Intervention; Intervention Studies; Intervention Trial; Laboratories; Malignant Childhood Neoplasm; Malignant Neoplasms; Monitor; National Clinical Trials Network; Nursing Research; Outcome; Patients; Peer Review; Policies; Procedures; Protocols documentation; Provider; Race; Reporting; Research; Research Personnel; Resources; Safety; Services; Socioeconomic Status; Tissues; Training and Education; Translations; Writing; clinical care; data integrity; data management; improved; insight; investigator-initiated trial; patient safety; prevent; quality assurance; research study; sex; therapy design

CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ABSTRACT The Case Comprehensive Cancer Center (Case CCC) is committed to the translation of laboratory insights into routine clinical care. This requires a deep infrastructure to support the conduct of clinical trials of new interventions designed to prevent, diagnose and treat cancer, and improve the long-term outcomes for cancer survivors. The Clinical Protocol and Data Management services of the Case CCC provide a centralized resource for the oversight and management of clinical trials from concept development through reporting of study results. Services include assistance with concept development and protocol writing; feasibility assessment; budgeting and contracting; research nursing and data management; database development and oversight; regulatory management including IND applications; interactions with sponsors; study registration; quality assurance; staff education; and reporting of results. Data and safety monitoring to ensure the integrity of data and patient safety is a critical centralized function. As our goal is to ensure access to clinical trials for all of our patients, special efforts are undertaken to provide the opportunity to participate in clinical trials regardless of sex/gender, race, ethnicity, socioeconomic status, or age. The Specific Aims are to: 1) Provide a highly efficient and coordinated infrastructure to assist clinical investigators in the development, conduct and reporting of clinical trials. 2) Oversee data integrity and ensure the safety of patients who participate in clinical trials. 3) Provide access to clinical trials for all cancer patients regardless of sex/gender, race, ethnicity, age, and socioeconomic status, and proactively identify and address barriers to clinical trial participation among patients, providers, research staff, and healthcare systems. 4) Support a robust portfolio of research studies relevant to children and address special considerations for children with cancer to facilitate their participation in clinical trials. In 2016, 2,474 patients were enrolled onto Case CCC interventional trials (73 percent increase since 2012), including 866 patients on treatment studies. In 2016, thirty one percent of accruals to treatment studies and seventy percent of all interventional accrual was to investigator-initiated trials (peer-reviewed, institutional). There is a substantial commitment to support of National Clinical Trials Network (NCTN) studies, with 209 patients accrued to treatment intervention studies in the third year of the NCTN. Furthermore, in 2016 the Case CCC enrolled and biopsied 93 patients on the NCI MATCH trial, supported by the Clinical Trials Units via rapid activation, centralized registration, and coordination of tissue acquisition and processing. !

临床协议和数据管理 项目摘要/摘要 案例综合癌症中心（案例CCC）致力于将实验室见解转化为 常规临床护理。这需要深入的基础设施来支持新的临床试验的行为 旨在预防，诊断和治疗癌症并改善癌症的长期结局的干预措施 幸存者。 CCC案件的临床协议和数据管理服务提供了集中资源 通过报告研究结果的监督和管理概念开发的临床试验。 服务包括概念开发和协议写作的帮助；可行性评估；预算 和收缩；研究护理和数据管理；数据库开发和监督；监管 包括IND申请在内的管理；与赞助商的互动；研究注册；质量保证；职员 教育;和结果报告。数据和安全监控以确保数据和患者安全的完整性 是关键的集中式函数。因为我们的目标是确保所有患者的临床试验访问 不管性别/性别，种族， 种族，社会经济地位或年龄。具体目的是： 1）提供高效且协调的基础设施，以帮助临床研究人员进行开发， 进行和报告临床试验。 2）监督数据完整性并确保参加临床试验的患者的安全。 3）为所有癌症患者提供临床试验，无论性别/性别，种族，种族，年龄和年龄如何 社会经济地位，并积极识别和解决与临床试验参与的障碍 患者，提供者，研究人员和医疗保健系统。 4）支持与儿童相关的研究研究组合的强大组合，并解决了特殊注意事项 癌症儿童以促进他们参与临床试验。 2016年，有2474名患者参加了病例CCC介入试验（自2012年以来增长73％）， 包括866例治疗研究患者。 2016年，有31％的应计治疗研究和 所有介入应计的百分之七十是研究者发起的试验（经过同行评审，机构）。那里 是支持国家临床试验网络（NCTN）研究的实质性承诺，有209名患者 在NCTN的第三年内应进行治疗干预研究。此外，2016年CCC案件 在NCI比赛试验中注册和活检93名患者，并通过快速临床试验单位支持 激活，集中式注册以及组织采集和加工的协调。 呢