Statistics and Data Center for the Alliance for Clinical Trials in Oncology

简介(申请人提供)：肿瘤学临床试验联盟(Alliance)成立于2011年7月15日，由癌症和白血病B组(CALGB)、北中癌症治疗组(NCCTG)和美国外科医学院肿瘤组(ACOSOG)三个遗留组合并而成。联盟统计和数据中心负责联盟的所有统计和数据管理需求。在萨金特博士作为联盟集团统计师的领导下，在合并后的短暂时间里，联盟SDC一直是、现在是一个完全整合的、单一的、全面的中心，拥有清晰的、经验丰富的领导结构，包括来自ACOSOG、CALGB和NCCTG SDC的遗留领导人。在保留16名传统高级统计教师中的15名的同时实现了这一点，为所有新的联盟临床试验实施了Medidata Rave，巩固了 到单一的信息系统基础设施，满足NCI业务效率工作组的所有时间表，并从联盟外部的调查人员那里开始6项临床试验。从2007年1月1日到2012年8月1日，Alliance SDC为开启的99项Alliance治疗临床试验提供了统计、数据管理和IT协作和支持，236项 在患者继续随访之前开始的试验，发表了296篇手稿，报告了联盟领导的临床试验、相关的相关研究或回顾研究。在整个申请过程中描述的成就表明，SDC已经快速有效地实现了所有遗留群体活动的整合，并正在积极追求未来联盟科学的统一战略。联盟SDC在许多情况下与癌症研究的科学、管理和技术领域的创新保持同步，并在许多情况下引领创新，并为迎接2014年及以后的癌症临床试验挑战做好了理想的准备。联盟的教师包括基于生物标记物的临床试验设计、适应性试验、生物信息学和早期临床试验设计的方法学负责人。SDC临床数据系统与联盟实验室完全集成，以允许将生物标记物实时集成到试验中，并促进联盟临床和生物数据的外部访问。联盟系统强大且可扩展，具有动态协作的能力：1)国际努力(例如N1048、Cio6o3、A091104)，2)完全在联盟外部的研究人员发起的试验(例如A091101、A91104)，3)罕见肿瘤试验(例如A091102、A091105)，并在必要时扩展到新的合作。联盟SDC是NCI/NCTN所有相关活动的正式合作伙伴，并致力于在新的NCTN计划中继续发挥其协作领导作用。

DESCRIPTION (provided by applicant): The Alliance for Clinical Trials in Oncology (Alliance) was formed on July 15, 2011 through the merger of 3 legacy groups: The Cancer and Leukemia Group B (CALGB), the North Central Cancer Treatment Group (NCCTG) and the American College of Surgeons Oncology Group (ACOSOG). The Alliance Statistics and Data Center (SDC) is responsible for all statistical and data management needs for the Alliance. Under the leadership of Dr. Sargent as the Alliance Group Statistician, in the brief span since the merger, the Alliance SDC has been and now is a completely integrated, single, comprehensive center with a clear, experienced leadership structure including legacy leaders from the ACOSOG, CALGB, and NCCTG SDCs. This has been accomplished while retaining 15 of 16 legacy senior statistical faculty, implementing Medidata Rave for all new Alliance clinical trials, consolidating to a single information systems infrastructure, meeting all NCI Operational Efficiency Working Group timelines, and opening 6 clinical trials from investigators external to the Alliance. From January 1, 2007 - August 1, 2012, the Alliance SDC provided statistical, data management, and IT collaboration and support for 99 Alliance treatment clinical trials that opened to accrual, 236 trials opened prior to that period for which patient follow-up was continuing, and published 296 manuscripts reporting on Alliance led clinical trials, associated correlative, or retrospective studies. The accomplishments described throughout this application demonstrate that the SDC has rapidly and effectively achieved integration of all legacy group activities and is actively pursuing a unified strategy for future Alliance science. The Alliance SDC has kept pace with and in many cases led innovation in the scientific, administrative, and technological arenas of cancer research, and is ideally poised to meet the challenges of cancer clinical trials in 2014 and beyond. Alliance faculty includes methodological leaders in biomarker-based clinical trial design, adaptive trials, bioinformatics, and early stage clinical trial design. SDC clinical data systems ae fully integrated with Alliance laboratories to allow real-time integration of biomarkers into trial as well as to facilitate external access to Alliance clinical and biologic data. Alliance systems ae robust and scalable, with demonstrated ability to dynamically collaborate with: 1) international efforts (e.g., N1048, Cio6o3, A091104), 2) trials initiated from investigators completely external to the Alliance (e.g., A091101, A91104), 3) rare tumor trials (e.g., A091102, A091105), and to expand to new collaborations as necessary. The Alliance SDC is a full partner in all relevant NCI/NCTN activities, and is committed to continuing its collaborative leadership role in the new NCTN program.