NRG Oncology Statistical and Data Management Center

NRG 肿瘤统计和数据管理中心

• 批准号: 9242576
• 负责人: JOSEPH P. COSTANTINO
• 金额: $ 1006.53万
• 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/9242576
• 关键词: Administrative Efficiency; American College of Radiology; Area; Biometry; Buffaloes; Cancer Patient; Chicago; Clinical Research; Clinical Research Associate; Clinical Trials; Communication; Correlative Study; Data; Data Analyses; Data Collection; Data Quality; Dedications; Disease; Electronic Mail; Ensure; Environment; Evaluation; Evidence Based Medicine; Gender; Goals; Gynecologic Oncology Group; Individual; Information Dissemination; 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; Modernization; Monitor; Morbidity - disease rate; National Cancer Institute; National Clinical Trials Network; National Surgical Adjuvant Breast and Bowel Project; Positioning Attribute; Procedures; Process; 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; Time; Training and Education; Transcend; Translational Research; Universities; breast malignancies; cancer therapy; 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; trial design; 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）：该提案的目的是建立和维护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是加入来自NCI癌症合作组NSABP，RTOG和GOG的传统SDMC的结果，该组织共同拥有超过150年的合并经验，以支持SDMC，以支持国家癌症研究所的临床试验研究工作。综合SDMC的不同背景是NRG肿瘤学执行跨越广泛疾病的研究组合的能力。它在性别特异性的恶性肿瘤中具有独特的集中度：乳腺癌，妇科癌，前列腺癌和晚期放射治疗技术，以及其他几种癌症的领先地位。这种经验和专业知识的广度成功整合建立了一系列临床研究，这些研究在任何其他NCTN研究实体中都不存在。 SDMC将确保开发这些领域的科学相关研究，以最先进的方法进行，并进行解释和呈现，以最大程度地对基于证据的医学产生影响。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，这种合作的SDMC在实现其目标（包括但不限于）方面具有独特的位置；协调传统SDMC的多样化知识，经验和资源，以创建独特的NRG肿瘤学SDMC，超越了其各个组成部分的卓越成就；充分参与领导能力，并确定该小组的科学方向；监督/参与NRG肿瘤学转化研究，临床试验和相关研究；提供有效的，方法论上最新的试验设计，监视，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进行分析；利用尖端信息技术（IT）强调数据收集和管理的数据完整性，安全性，及时性和效率；为机构临床研究协会，研究主席以及参与NRG肿瘤学研究议程的其他人提供教育和培训；为技术活动提供建议和协作支持BF NRG肿瘤学，例如网站设计和维护，促进与会员的大众传播以及类似功能；并监督NRG肿瘤质量保证审核计划的实施，进行和评估。最后，所有SDMC部门与彼此之间以及与NRG肿瘤学的成功合作的可靠能力是建立尖端科学的基石。