NRG Oncology Statistical and Data Management Center

描述（由申请人提供）：本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是加入来自三个NCI癌症合作组（NSABP，RTOG和GOG）的传统SDMC的结果，这些合作组共同拥有超过150年的运营SDMC的综合经验，以支持国家癌症研究所的临床试验研究工作。综合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。它在性别特异性恶性肿瘤方面具有独特的浓度：乳腺癌，妇科癌症，前列腺癌和先进的放射治疗技术，以及在其他几种癌症中的领先地位。这种广泛的经验和专业知识的成功整合建立了一个临床研究的跨度，不存在于任何其他NCTN研究实体。SDMC将确保这些领域的科学相关研究得到开发，采用最先进的方法进行，并进行解释和介绍，以最大限度地提高对循证医学的影响。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，该协作SDMC处于独特的地位，可以实现其目标，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性;全面参与领导和确定集团的科学方向;监督/参与NRG肿瘤转化研究、临床试验活动和相关研究;提供有效的、方法学上最新的试验设计、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进行分析;利用尖端的信息技术（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肿瘤科的技术活动提供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以及类似职能;并监督NRG肿瘤科质量保证审计计划的实施、执行和评估。最后，所有SDMC部门相互之间以及与NRG肿瘤学部门成功合作的能力已得到证明，这是建立尖端科学的基石。

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.