Clinical Protocol and Data Management

临床方案和数据管理 项目摘要/摘要 病例综合癌症中心(Case CCC)致力于将实验室的见解转化为 常规的临床护理。这需要一个深入的基础设施来支持进行新的临床试验 旨在预防、诊断和治疗癌症并改善癌症长期结果的干预措施 幸存者。Case CCC的临床方案和数据管理服务提供了一个集中的资源 从概念开发到研究结果报告，对临床试验进行监督和管理。 服务包括协助概念制定和协议编写；可行性评估；预算编制。 和合同；研究护理和数据管理；数据库开发和监督；监管 管理包括IND申请；与赞助商的互动；学习注册；质量保证；工作人员 教育；以及成果报告。数据和安全监控，确保数据的完整性和患者的安全 是一项关键的集中职能。因为我们的目标是确保我们所有的患者都能获得临床试验，特别是 努力提供参与临床试验的机会，不分性别/性别、种族、 种族、社会经济地位或年龄。具体目标是： 1)提供高效和协调的基础设施，以协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，确保参与临床试验患者的安全。 3)为所有癌症患者提供临床试验，不分性别、种族、民族、年龄和 社会经济地位，并主动识别和解决参与临床试验的障碍 患者、提供者、研究人员和医疗保健系统。 4)支持与儿童有关的强有力的研究组合，并解决以下方面的特殊考虑 帮助癌症儿童参与临床试验。 2016年，2474名患者参加了Case CCC干预试验(自2012年以来增加了73%)， 包括866名正在进行治疗研究的患者。2016年，31%的应计收益用于治疗研究和 所有干预收益的70%用于研究人员发起的试验(同行评议，机构)。那里 是对支持国家临床试验网络(NCTN)研究的重大承诺，该网络拥有209名患者 在NCTN的第三年进行治疗干预研究。此外，在2016年，CCC案 在NCI Match试验中登记并活组织检查了93名患者，由临床试验单位通过RAPID提供支持 组织采集和处理的激活、集中注册和协调。 好了！

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. !