Data Management Core

数据管理核心

• 批准号: 10360617
• 负责人: Sumithra Jay Mandrekar
• 金额: $ 474.5万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-17 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10360617
• 关键词: American College of Surgeons Oncology Group; Basic Science; Bioinformatics; Biological Markers; Cancer Patient; Cancer and Leukemia Group B; Cessation of life; Clinic; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Computer software; Correlative Study; Data; Data Collection; Development; Ensure; Evaluation; Faculty; Information Systems; Information Technology; Infrastructure; International; Lead; Leadership; Location; Manuscripts; Medidata; Methodology; Methods; Mission; Monitor; North Central Cancer Treatment Group; Oncology; Paper; Patients; Phase I Clinical Trials; Policies; Positioning Attribute; Precision Medicine Initiative; Preparation; Procedures; Process; Publications; Publishing; Regulation; Reporting; Retrospective Studies; Secure; Source; Support System; Surrogate Endpoint; System; TimeLine; Training Programs; Translational Research; Translations; anticancer research; base; cancer clinical trial; clinical practice; data management; data quality; design; editorial; electronic data; follow-up; genomic biomarker; genomic predictors; improved outcome; individual patient; innovation; instrument; member; novel; novel therapeutics; prospective; quality assurance; statistics; tool; treatment trial

The Alliance for Clinical Trials in Oncology (Alliance) was founded on July 15, 2011, through the merger of 3 legacy groups: Cancer and Leukemia Group B, North Central Cancer Treatment Group, and American College of Surgeons Oncology Group. The Alliance Statistics and Data Management Center (SDMC) is responsible for all statistics, data management, and Information Technology functions for the Alliance and, as such, is an integral part of the Alliance’s mission. Despite being formed from 3 distinctive groups, all SDMC activities are now consolidated at a single location at the Mayo Clinic under the leadership of Dr. Sumithra Mandrekar as the Alliance Group Statistician, all while undergoing a leadership transition due to the untimely death of the previous group statistician, Dr. Daniel Sargent. Alliance faculty includes methodological leaders in biomarker-based clinical trial design, adaptive trials, surrogate endpoint evaluations, development of methodology and computing tools for identification of predictive genomic markers, and early-stage clinical trial design. From March 1, 2014 – August 31, 2017, the SDMC provided statistical, data management, and IT collaboration for 20 treatment trials currently in development, 21 treatment trials that opened to accrual and, 100 trials that opened prior to March 2014, for which patient follow-up or manuscript preparation is in progress. SDMC members were authors on 234 published manuscripts reporting on Allianceled clinical trials and associated correlative or retrospective studies, authored an additional 149 reviews, editorials, or position papers on novel statistical and bioinformatics methods, analyses and software, and provided substantial statistical support and leadership on 44 publications which leverage individual patient data from multiple Alliance studies. SDMC systems are robust and scalable and support all needs of the Alliance. The SDMC has implemented Medidata Rave for all trials, consolidated to a single information systems infrastructure, met all NCI OEWG timelines, collaborated on international trials, partnered on prospective and retrospective registration trials, and is leading the ALCHEMIST trial, A151216 (part of the NCI precision medicine initiative). The SDMC has contributed to several national NCTN systems initiatives: piloting of the ePRO system, Source Data Verification, integrations between Rave and CTEPAERs, implementing the Data Quality Portal and Central Monitoring Portal, and partnering on the NCTN Biospecimen Navigator. The Alliance SDMC has kept pace with, and in many cases led, innovation in scientific, administrative, and technological arenas of cancer research, and is ideally poised to meet the challenges of cancer clinical trials in 2018 and beyond.

肿瘤学临床试验联盟（Alliance）成立于2011年7月15日，通过 合并 3 个遗留组：癌症和白血病 B 组、中北部癌症治疗 组和美国外科医师学会肿瘤学组联盟统计和数据。 管理中心（SDMC）负责所有统计、数据管理和信息 技术为联盟发挥作用，因此是联盟使命的一个组成部分。 尽管 SDMC 由 3 个不同的小组组成，但所有 SDMC 活动现已合并为 梅奥诊所 (Mayo Clinic) 的单一地点，由 Sumithra Mandrekar 博士领导 联盟集团统计员，由于不合时宜，正在经历领导层过渡 联盟前任统计学家丹尼尔·萨金特博士的去世包括。 基于生物标志物的临床试验设计、适应性试验、替代方法的方法学领导者 终点评估、开发方法和计算工具以识别 预测基因组标记和早期临床试验设计 2014 年 3 月 1 日至 8 月。 2017 年 12 月 31 日，SDMC 为 20 家企业提供了统计、数据管理和 IT 协作服务。 目前正在开发治疗试验，21 项治疗试验已开放，100 项 2014 年 3 月之前开始的试验，其中患者随访或稿件准备工作 SDMC 成员是 234 篇关于 Allianceled 的已发表手稿的作者。 临床试验和相关的相关或回顾性研究，另外撰写了 149 关于新颖的统计和生物信息学方法、分析的评论、社论或立场文件 和软件，并为 44 种出版物提供了大量的统计支持和领导 它利用了多个 SDMC 系统的个体患者数据，非常稳健。 且可扩展并支持联盟的所有需求 SDMC 已实施 Medidata Rave。 所有试验均整合至单一信息系统基础设施，满足所有 NCI OEWG 要求 时间表、国际试验合作、前瞻性和回顾性合作 注册试验，并领导 ALCHEMIST 试验 A151216（NCI 精密试验的一部分） SDMC 为多项国家 NCTN 系统举措做出了贡献： ePRO 系统试点、源数据验证、Rave 和 CTEPAER 之间的集成、 实施数据质量门户和中央监控门户，并合作 NCTN 生物样本导航器在许多情况下都与联盟 SDMC 保持同步。 领导癌症研究的科学、管理和技术领域的创新，并且 已做好充分准备迎接 2018 年及以后癌症临床试验的挑战。