Clinical Protocol and Data Management

临床方案和数据管理

基本信息

批准号：
10784831
负责人：
Aaron Thomas Gerds
金额：
$ 75.31万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-08-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10784831
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 Support 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

项目摘要

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. !

临床方案和数据管理项目概要/摘要凯斯综合癌症中心 (Case CCC) 致力于将实验室见解转化为常规临床护理。这需要深厚的基础设施来支持新药临床试验的进行旨在预防、诊断和治疗癌症以及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集中资源用于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；预算编制和承包；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；职员教育;和结果报告。数据和安全监控，确保数据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参与临床试验，因此特别我们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、协调的基础设施来协助临床研究人员开发、临床试验的进行和报告。 2) 监督数据完整性并确保参与临床试验的患者的安全。 3) 为所有癌症患者提供参与临床试验的机会，无论性别、种族、民族、年龄和性别社会经济地位，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) 支持与儿童相关的强有力的研究组合，并解决儿童的特殊考虑癌症儿童，以促进他们参与临床试验。 2016 年，2,474 名患者参加了 Case CCC 介入试验（自 2012 年以来增加了 73%），包括 866 名接受治疗研究的患者。 2016 年，百分之三十一的应计费用用于治疗研究和所有干预应计项目的 70% 是由研究者发起的试验（同行评审、机构试验）。那里是对支持国家临床试验网络 (NCTN) 研究的重大承诺，该网络有 209 名患者参与 NCTN 第三年的治疗干预研究累积。此外，2016年CCC案例在临床试验单位的支持下，通过快速激活、集中注册以及组织采集和处理的协调。！