Interagency Collaboration for Patient-Centered Antibacterial Drug Development

Jessica Howard-Anderson, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Sarah B. Doernberg, Division of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
Dennis Dixon, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Ramya Gopinath, Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Daniel Rubin, Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Tori Kinamon, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Peter Kim, Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Deborah Collyar, Patient Advocates in Research (PAIR), Danville, California, USA.
Sara E. Cosgrove, Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Vance G. Fowler, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Henry F. Chambers, Division of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
Scott R. Evans, Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, D.C., USA.
Thomas L. Holland, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Heather A. King, Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, North Carolina, USA.
Helen W. Boucher, Tufts University School of Medicine and Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, Massachusetts, USA.

Document Type

Journal Article

Publication Date

8-6-2025

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Volume

81

Issue

Supplement_1

DOI

10.1093/cid/ciaf298

Keywords

antibacterial; desirability of outcome ranking; drug development; health-related quality of life; patient-centered

Abstract

This manuscript presents key advances of the Antibacterial Resistance Leadership Group (ARLG) Innovations Task Force, a collaboration focused on improving endpoints for registrational trials of antibacterial drugs, including health-related quality-of-life measures, for common acute infections. This group includes members from the United States Food and Drug Administration, National Institutes of Health, academia, industry, and patient representatives to amplify patient voices and ensure that the endpoints are meaningful to how patients feel, function, and survive.

Department

Biostatistics and Bioinformatics

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