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.

Keywords: antibacterial resistance; data; innovation.; statistics.

Figure 1.

Fundamental Statistical and Data Management Center activities during the lifecycle of a study. Abbreviations: ARLG, Antibacterial Resistance Leadership Group; CONSORT, Consolidated Standards of Reporting Trials; eCRF, electronic case report form; EDC, electronic data capture; EHR, electronic health record; IRB, institutional review board; SDMC, Statistical and Data Management Center; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; STARD, Standards for Reporting of Diagnostic Accuracy Studies.