@article{4e58957a4fb9420f8a6c4ebf62bb4c37,
title = "White paper: Recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens",
abstract = "There is a critical need for new pathways to develop antibacterial agents to treat life-threatening infections caused by highly resistant bacteria. Traditionally, antibacterial agents have been studied in noninferiority clinical trials that focus on one site of infection (eg, pneumonia, intra-abdominal infection). Conduct of superiority trials for infections caused by highly antibiotic-resistant bacteria represents a new, and as yet, untested paradigm for antibacterial drug development. We sought to define feasible trial designs of antibacterial agents that could enable conduct of superiority and organism-specific clinical trials. These recommendations are the results of several years of active dialogue among the white paper's drafters as well as external collaborators and regulatory officials. Our goal is to facilitate conduct of new types of antibacterial clinical trials to enable development and ultimately approval of critically needed new antibacterial agents.",
author = "Brad Spellberg and Brass, \{Eric P.\} and Bradley, \{John S.\} and Lewis, \{Roger J.\} and David Shlaes and Ambrose, \{Paul G.\} and Anita Das and Boucher, \{Helen W.\} and Yohei Doi and Bartlett, \{John G.\} and Bonomo, \{Robert A.\} and Larosa, \{Steven P.\} and Talbot, \{George H.\} and Daniel Benjamin and Robert Guidos and Amanda Jezek and Gilbert, \{David N.\}",
note = "Funding Information: Potential conflicts of interest. Brad Spellberg{\textemdash}grant and contract support: National Institutes of Health, Cubist, Pfizer, Eisai, The Medicines Company, and Bristol Myers Squibb (BMS); GlaxoSmithKline (GSK), Pfizer, Eisai, Meiji, Polymedix, Adenium, Novartis, Anacor, The Medicines Company, and Basilea. Eric P. Brass{\textemdash}Sigma Tau Pharmaceuticals, GSK, Consumer Healthcare Products Association, Kowa Research Institute, Maple Leaf Ventures/Worldwide Clinical Trials, Novo Nordisk, 3D Communications, Catabasis Pharmaceuticals, Allergan, Medtronic, NovaDigm Therapeutics, Arena Pharmaceuticals, Bayer, Amgen, World Self-Medication Industry, Optimer Pharmaceuticals, Gen-Probe, AtriCure, Talon Therapeutics, Merck, NeurogesX, Ironwood Pharmaceuticals, NPS Pharmaceuticals, HeartWare International, Johnson \& Johnson ( J\&J)/ McNeil, and Takeda Pharmaceuticals; equity in Calistoga Pharmaceuticals and Catabasis Pharmaceuticals. Roger Lewis{\textemdash}senior medical scientist for Berry Consultants, LLC; consultant to AspenBio Pharma and Roche Diagnostics; chair or member of data and safety monitoring boards (DSMBs) for clinical trials sponsored by multiple institutes of the National Institutes of Health, as well as Octapharma USA and Octapharma AG. David Shlaes {\textemdash}AstraZeneca, GSK, J\&J, Sanofi-Aventis, Achillion, Actelion, AtoxBio, Cempra, Furiex, IOTA, Indel, Nabriva, Nosopharm, Polyphor, Tetraphase, Abingworth, Novo, Phase IV, Ventech, and Longitude. Paul Ambrose{\textemdash}research at the Institute for Clinical Pharmacodynamics has been funded by Achaogen, Actelion, Astellas, AstraZeneca, B. Braun Medical, BMS, Cempra, Cerexa, Cubist, Durata, Eli Lilly and Company, Elusys Therapeutics, Ferdora Pharmaceuticals, Forest Research Institute, Furiex Pharmaceutical, GSK, InterMune, ISMED Inc, Janssen Research \& Development, Kalidex Pharmaceuticals, The Medicines Company, Meiji Seika Pharma Co, Microbiotix, Nabriva, Nimbus, Pfizer, PTC Therapeutics, Rib-X, Roche, Seachaid Pharmaceutical, Synteract Inc, Tetraphase, and Zogenix. Anita Das{\textemdash}consultant through AxiStat to Achaogen, Cerexa, Cempra, Cubist, Trius, Durata, Nabriva, and Kalidex. Helen Boucher{\textemdash}Basilea, Cerexa, Durata, Merck (adjudication committee), J\&J, Rib-X, Targanta/ TMC, and Wyeth/Pfizer (DSMB). Yohei Doi{\textemdash}research support to Merck; advisory board of Pfizer. Steven Larosa{\textemdash}consultant fees from Agennix AG and ExThera Medical. George H. Talbot{\textemdash}through Talbot Advisors LLC: board compensation and/or consultancy fees from Actelion, Basilea, Bayer, Cempra, Cerexa, Durata, Cubist-Calixa, FAB Pharma, J\&J, Kalidex, Meiji, Merada, Merck, Nabriva, and Wyeth/Pfizer (DSMB); equity interests in Durata, Calixa, Cempra, Cerexa, Kalidex, Mpex, and Nabriva. David N. Gilbert{\textemdash}consultant for Achaogen and Pfizer. Daniel Benjamin{\textemdash} research grants from Astellas, AstraZeneca, and UCB Pharma; consultant for Astellas, Biosynexus, Cubist, J\&J, Merck, Pfizer, and The Medicines Company. All other authors report no potential conflicts.",
year = "2012",
month = oct,
day = "15",
doi = "10.1093/cid/cis688",
language = "English",
volume = "55",
pages = "1031--1046",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "8",
}
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