Under the Hood: The Scientific Leadership, Clinical Operations, Statistical and Data Management, and Laboratory Centers of the Antibacterial Resistance Leadership Group

Developing and implementing the scientific agenda of the Antibacterial Resistance Leadership Group (ARLG) by soliciting input and proposals, transforming concepts into clinical trials, conducting those trials, and translating trial data analyses into actionable information for infectious disease cli...

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Published inClinical infectious diseases Vol. 77; no. Suppl 4; pp. S288 - S294
Main Authors Cross, Heather R, Greenwood-Quaintance, Kerryl E, Souli, Maria, Komarow, Lauren, Geres, Holly S, Hamasaki, Toshimitsu, Chambers, Henry F, Fowler, Vance G, Evans, Scott R, Patel, Robin
Format Journal Article
LanguageEnglish
Published United States Oxford University Press 16.10.2023
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Summary:Developing and implementing the scientific agenda of the Antibacterial Resistance Leadership Group (ARLG) by soliciting input and proposals, transforming concepts into clinical trials, conducting those trials, and translating trial data analyses into actionable information for infectious disease clinical practice is the collective role of the Scientific Leadership Center, Clinical Operations Center, Statistical and Data Management Center, and Laboratory Center of the ARLG. These activities include shepherding concept proposal applications through peer review; identifying, qualifying, training, and overseeing clinical trials sites; recommending, developing, performing, and evaluating laboratory assays in support of clinical trials; and designing and performing data collection and statistical analyses. This article describes key components involved in realizing the ARLG scientific agenda through the activities of the ARLG centers.
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S. R. E. and R. P. contributed equally to this work.
Potential conflicts of interest. All authors report funding support to the Antibacterial Resistance Leadership Group (ARLG) from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH) (UM1AI104681). H. R. C., M. S., and H. S. G. report salary support from the ARLG via Duke University. T. H. reports consulting fees from Tanabe-Mitsubishi Pharma and honoraria from Duke University and the Japanese Journal of Cancer and Chemotherapy Publishers, Inc. H. F. C. reports royalties from the Sanford Guide to Antimicrobial Therapy, payment for expert testimony from Nexus Pharmaceuticals, participation on a Merck data safety monitoring board for molnupiravir, and stock ownership in Moderna and Merck. V. G. F. reports personal consulting fees from Novartis, Debiopharm, Genentech, Achaogen, Affinium, The Medicines Company, MedImmune, Bayer, Basilea, Affinergy, Janssen, Contrafect, Regeneron, Destiny, Amphliphi Biosciences, Integrated Biotherapeutics, C3J, Armata, Valanbio, Akagera, Aridis, Roche, and Pfizer (paid to author); grants from the NIH, MedImmune, Allergan, Pfizer, Advanced Liquid Logics, Theravance, Novartis, Merck, Medical Biosurfaces, Locus, Affinergy, Contrafect, Karius, Genentech, Regeneron, Deep Blue, Basilea, and Janssen; royalties from UpToDate; stock options from Valanbio and ArcBio; honoraria from the Infectious Diseases Society of America for service as associate editor of Clinical Infectious Diseases; travel support from ContraFect to the 2019 European Congress of Clinical Microbiology and Infectious Diseases; and a sepsis diagnostics patent pending. S. R. E. reports grants from the National Institute of Allergy and Infectious Diseases and the NIH and De Gruyter (as editor-in-chief for Statistical Communications in Infectious Diseases); royalties from Taylor & Francis; consulting fees from Genentech, AstraZeneca, Takeda, Microbiotix, Johnson & Johnson, Endologix, ChemoCentryx, Becton Dickinson, Atricure, Roviant, Neovasc, Nobel Pharma, Horizon, the International Drug Development Institute, SVB Leerink, Medtronic, Regeron, Wake Forest University, Recor, Janssen, and IDDI; payments from Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks; meeting support from the US Food and Drug Administration, the Deming Conference on Applied Statistics, the Clinical Trial Transformation Initiative, the Council for International Organizations of Medical Sciences, the International Chinese Statistical Association Applied Statistics Symposium, and the Antimicrobial Resistance and Stewardship Conference; and board member participation for the NIH, Breast International Group, the University of Pennsylvania, Washington University, Duke University, Roche, Pfizer, Takeda, Akouos, Apellis, Teva, Vir, DayOneBio, Alexion, Tracon, Rakuten, Abbvie, GSK, Eli Lilly, Nuvelution, Clover, FHI Clinical, Lung Biotech, SAB Biopharm, Advantagene, Candel, Novartis, the American Statistical Association, Society for Clinical Trials, and the Frontier Science Foundation. R. P. reports grants or contracts from ContraFect, TenNor Therapeutics, BIOFIRE, and Adaptive Phage Therapeutics; a royalty-bearing know-how agreement and equity in Adaptive Phage Therapeutics through the Mayo Clinic; consulting fees from PhAST, Torus Biosystems, Day Zero Diagnostics, Mammoth Biosciences, HealthTrackRx, Netflix, Abbott Laboratories, Trellis Bioscience, Oxford Nanopore Technologies, and CARB-X; honoraria from the National Board of Medical Examiners, Up-to-Date, and the Infectious Diseases Board Review Course; a patent on Bordetella pertussis/parapertussis polymerase chain reaction issued, a patent on a device/method for sonication with royalties paid by Samsung to Mayo Clinic, and a patent on an anti-biofilm substance issued; and a financial relationship with Pathogenomix through the Mayo Clinic. All other authors report no potential conflicts.
All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
ISSN:1058-4838
1537-6591
1537-6591
DOI:10.1093/cid/ciad529