title: Fundamentals and Catalytic Innovation: The Statistical and Data Management Center of the Antibacterial Resistance Leadership Group.
abstract: 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.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Huvane
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
authors.forename: Lauren
authors.initials: L
authors.lastname: Komarow
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
authors.forename: Carol
authors.initials: C
authors.lastname: Hill
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
authors.forename: Thuy Tien T
authors.initials: TT
authors.lastname: Tran
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
authors.forename: Carol
authors.initials: C
authors.lastname: Pereira
authors.affiliation: Frontier Science & Technology Research Foundation, Boston, Massachusetts.
authors.forename: Susan L
authors.initials: SL
authors.lastname: Rosenkranz
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
authors.forename: Matt
authors.initials: M
authors.lastname: Finnemeyer
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
authors.forename: Michelle
authors.initials: M
authors.lastname: Earley
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
authors.forename: Hongyu Jeanne
authors.initials: HJ
authors.lastname: Jiang
authors.affiliation: Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, and.|Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Rui
authors.initials: R
authors.lastname: Wang
authors.affiliation: Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Judith
authors.initials: J
authors.lastname: Lok
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.|Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Evans
mesh_terms: D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use; D003625:Data Collection; D024881:Drug Resistance, Bacterial; D004501:Education, Medical; D006295:Health Resources; D006801:Humans; D019451:Information Management / Q000379:methods* / Q000458:organization & administration* / Q000592:standards; D012106:Research
chemical_list: D000900:Anti-Bacterial Agents
keywords: antibacterial resistance; data; innovation.; statistics