Clinical Protocol and Data Management

临床方案和数据管理 项目概要/摘要 病例综合癌症中心（Case CCC）致力于将实验室见解转化为 常规临床护理。这需要一个深入的基础设施来支持新的临床试验的进行。 旨在预防、诊断和治疗癌症并改善癌症长期结局的干预措施 幸存者病例CCC的临床方案和数据管理服务提供集中资源 监督和管理临床试验，从概念开发到研究结果报告。 服务包括协助概念开发和方案编写;可行性评估;预算编制 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;与申办者的互动;研究注册;质量保证;工作人员 教育;和报告结果。数据和安全性监测，以确保数据的完整性和患者安全 是一个关键的集中功能。由于我们的目标是确保所有患者都能进入临床试验， 正在努力提供参与临床试验的机会，无论性别，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，以协助临床研究者进行开发， 开展和报告临床试验。 2)监督数据的完整性，确保参与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、种族、民族、年龄和 社会经济状况，并积极识别和解决参与临床试验的障碍， 患者、供应商、研究人员和医疗保健系统。 4)支持与儿童相关的一系列强有力的研究，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，2,474名患者参加了Case CCC干预性试验（自2012年以来增加了73%）， 包括866名接受治疗研究的患者。2016年，治疗研究和 70%的干预性累积是由制药商发起的试验（同行评审，机构）。那里 是一个实质性的承诺，以支持国家临床试验网络（NCTN）的研究，与209名患者 在NCTN的第三年进行治疗干预研究。此外，2016年，案例CCC 在NCI MATCH试验中招募并活检了93名患者，由临床试验部门通过快速 激活、集中登记以及组织采集和处理的协调。 !

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. !