NRG Oncology Statistical and Data Management Center

NRG 肿瘤统计和数据管理中心

• 批准号: 8605632
• 负责人: JOHN A BLESSING
• 金额: $ 900.31万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-18 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8605632
• 关键词: Administrative Efficiency; American College of Radiology; Area; Biometry; Buffaloes; Cancer Patient; Chicago; Clinical Research; Clinical Research Associate; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Communication; Correlative Study; Data; Data Analyses; Data Collection; Data Quality; Dedications; Disease; Electronics; Ensure; Environment; Evaluation; Evidence Based Medicine; Gender; Goals; Gynecologic Oncology Group; Individual; Information Technology; Institute of Medicine (U.S.); Journals; Knowledge; Leadership; Maintenance; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of prostate; Methodology; Methods; Modality; Monitor; Morbidity - disease rate; National Cancer Institute; National Surgical Adjuvant Breast and Bowel Project; Personal Satisfaction; Positioning Attribute; Procedures; Productivity; Public Health; Publications; Quality Control; Quality of life; Radiation Therapy Oncology Group; Radiation therapy; Reporting; Research; Research Activity; Research Infrastructure; Resources; Roswell Park Cancer Institute; Science; Security; System; Talents; Technology; Training and Education; Transcend; Translational Research; Universities; cancer therapy; computerized data processing; cost efficient; data integrity; data management; design; experience; improved; innovation; malignant breast neoplasm; mortality; novel; oncology; organizational structure; programs; public health relevance; quality assurance; sound; web page; web site

DESCRIPTION (provided by applicant): The objective of this proposal is to establish and maintain the Statistical and Data Management Center (SDMC) of the NRG Oncology National Clinical Trials Network (NCTN) Group. The SDMC is the result of joining the Legacy SDMCs from three NCI Cancer Cooperative Groups, the NSABP, RTOG and GOG, which together have over 150 years of combined experience operating SDMCs in support of the clinical trial research effort of the National Cancer Institute. The diverse background of the integrated SDMC is integral to NRG Oncology's ability to execute a research portfolio that spans a broad spectrum of diseases. It has a unique concentration in gender-specific malignancies: breast cancer, gynecologic cancer, prostate cancer, and advanced radiation therapy technology, as well as a leading presence in several other cancers. The successful integration of this breadth of experience and expertise establishes a span of clinical research that does not exist in any other NCTN research entity. The SDMC will ensure that scientifically relevant research in these areas is developed, conducted with state-of-the-art methodology, and interpreted and presented to maximize impact on evidence-based medicine. With its organizational structure, disease expertise, noteworthy experience, and focused dedication, this collaborative SDMC is uniquely positioned to achieve its goals including but not limited to; harmonize the diverse knowledge, experience, and resources of the Legacy SDMCs to create a unique NRG Oncology SDMC that transcends the established excellence of its individual components; participate fully in leadership and the determination of the Group's scientific direction; oversee/participate in NRG Oncology translational research, clinical trial activities and correlative studies; provide efficiet, methodologically up-to-date trial design, monitoring, reporting, and analysis; provide comprehensive data management/quality control to ensure high quality and timely data for analysis; leverage cutting edge information technology (IT) emphasizing data integrity, security, timeliness, and efficiency of data collection and management; provide education and training for institutional Clinical Research Associates, Study Chairs, and others involved in the NRG Oncology research agenda; provide IT advice and collaborative support for technologic activities bf NRG Oncology, such as website design and maintenance, facilitation of mass communication with membership, and similar functions; and oversee implementation, conduct, and evaluation of the NRG Oncology Quality Assurance Audit Program. Finally, the proven ability of all SDMC Divisions to collaborate successfully with one another, as well as with NRG Oncology, is a cornerstone upon which cutting edge science will be built.

描述(由申请人提供)：本提案的目标是建立和维护NRG肿瘤学国家临床试验网络(NCTN)组的统计和数据管理中心(SDMC)。SDMC是加入三个NCI癌症合作小组--NSABP、RTOG和GOG--的传统SDMC的结果，这三个小组总共拥有150多年运营SDMC的经验，支持国家癌症研究所的临床试验研究工作。整合的SDMC的多样化背景是NRG肿瘤学执行跨越广泛疾病的研究组合的能力不可或缺的一部分。它在特定性别的恶性肿瘤方面具有独特的集中度：乳腺癌、妇科癌症、前列腺癌和先进的放射治疗技术，在其他几种癌症中也处于领先地位。这种广泛的经验和专业知识的成功整合建立了一个在任何其他NCTN研究实体中都不存在的临床研究范围。国家发改委将确保在这些领域开展科学相关的研究，以最先进的方法进行，并进行解释和展示，以最大限度地影响循证医学。凭借其组织结构、疾病专业知识、值得注意的经验和专注的奉献精神，这个协作的SDMC在实现其目标方面具有独特的地位，包括但不限于：协调传统SDMC的各种知识、经验和资源，以创建一个独特的NRG肿瘤学SDMC，超越其单个组件的既定卓越；全面参与领导和确定集团的科学方向；监督/参与NRG肿瘤学翻译研究、临床试验活动和相关研究；提供高效、方法上最新的试验设计、监测、报告和分析；提供全面的数据管理/质量控制，以确保高质量和及时的数据用于分析；利用尖端信息技术(IT)，强调数据的完整性、安全性、及时性和数据收集和管理的效率；为机构临床研究助理、研究主席和其他参与NRG肿瘤学研究议程的人员提供教育和培训；为NRG肿瘤学的技术活动提供IT建议和协作支持，如网站设计和维护、促进与会员的大众沟通和类似功能；以及监督NRG肿瘤学质量保证审计计划的实施、实施和评估。最后，SDMC所有部门之间以及与NRG肿瘤学成功合作的证明能力，是尖端科学将建立在其基础上的基石。