title: MASTERMIND: Bringing Microbial Diagnostics to the Clinic.
abstract: New diagnostics are urgently needed to address emerging antimicrobial resistance. The Antibacterial Resistance Leadership Group proposes a strategy called MASTERMIND (Master Protocol for Evaluating Multiple Infection Diagnostics) for advancement of infectious diseases diagnostics. The goal of this strategy is to generate the data necessary to support US Food and Drug Administration clearance of new diagnostic tests by promoting research that might not have otherwise been feasible with conventional trial designs. MASTERMIND uses a single subject's sample(s) to evaluate multiple diagnostic tests at the same time, providing efficiencies of specimen collection and characterization. MASTERMIND also offers central trial organization, standardization of methods and definitions, and common comparators.
authors.affiliation: Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, and Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, Minnesota; patel.robin@mayo.edu.
authors.forename: Robin
authors.initials: R
authors.lastname: Patel
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Ephraim L
authors.initials: EL
authors.lastname: Tsalik
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Petzold
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, North Carolina.
authors.forename: Vance G
authors.initials: VG
authors.lastname: Fowler
authors.affiliation: David Geffen School of Medicine and Fielding School of Public Health, University of California, Los Angeles; and.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Klausner
authors.affiliation: Center for Biostatistics in AIDS Research and the Department of Biostatistics, Harvard University, Boston, Massachusetts.
authors.forename: Scott
authors.initials: S
authors.lastname: Evans
mesh_terms: D003141:Communicable Diseases / Q000175:diagnosis*; D024881:Drug Resistance, Bacterial; D006801:Humans; D008828:Microbiological Techniques / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
keywords: communicable diseases; molecular diagnostic techniques; reference standards.