title: Antibacterial drug development: challenges, recent developments, and future considerations.
abstract: A decline in antibacterial drug development coupled with emerging bacterial resistance has resulted in limited treatment options. One of the challenges facing antibacterial drug development is appropriate clinical trial designs. Noninferiority trials are appropriate to study new antibacterial drugs for the treatment of serious diseases; superiority trials can be challenging and cannot be the only acceptable trial design to study antibacterial drugs. Our efforts must continue to make new therapies available to meet patient needs.
authors: Division of Anti-Infective Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors: S
authors: S
authors: Nambiar
authors: Division of Anti-Infective Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors: K
authors: K
authors: Laessig
authors: Office of Antimicrobial Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors: J
authors: J
authors: Toerner
authors: Office of Antimicrobial Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors: J
authors: J
authors: Farley
authors: Office of Antimicrobial Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors: E
authors: E
authors: Cox
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000453:epidemiology; D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends; D055808:Drug Discovery / Q000379:methods / Q000639:trends*; D024901:Drug Resistance, Multiple, Bacterial / Q000187:drug effects* / Q000502:physiology; D005544:Forecasting; D006801:Humans
chemical_list: D000900:Anti-Bacterial Agents