Huvane Jacqueline, Komarow Lauren, Hill Carol, Tran Thuy Tien T, Pereira Carol, Rosenkranz Susan L, Finnemeyer Matt, Earley Michelle, Jiang Hongyu Jeanne, Wang Rui, Lok Judith, Evans Scott R
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
Clin Infect Dis. 2017 Mar 15;64(suppl_1):S18-S23. doi: 10.1093/cid/ciw827.
The Statistical and Data Management Center (SDMC) provides the Antibacterial Resistance Leadership Group (ARLG) with statistical and data management expertise to advance the ARLG research agenda. The SDMC is active at all stages of a study, including design; data collection and monitoring; data analyses and archival; and publication of study results. The SDMC enhances the scientific integrity of ARLG studies through the development and implementation of innovative and practical statistical methodologies and by educating research colleagues regarding the application of clinical trial fundamentals. This article summarizes the challenges and roles, as well as the innovative contributions in the design, monitoring, and analyses of clinical trials and diagnostic studies, of the ARLG SDMC.
统计与数据管理中心（SDMC）为抗菌药物耐药性领导小组（ARLG）提供统计和数据管理专业知识，以推进ARLG的研究议程。SDMC在研究的各个阶段都发挥着积极作用，包括设计、数据收集与监测、数据分析与存档以及研究结果的发表。SDMC通过开发和实施创新实用的统计方法，并就临床试验基本原理的应用对研究同事进行培训，提高了ARLG研究的科学完整性。本文总结了ARLG SDMC在临床试验和诊断研究的设计、监测及分析中的挑战与作用，以及创新贡献。
