title: FDA guidance for ABSSSI trials: implications for conducting and interpreting clinical trials.
abstract: Recent guidance from the US Food and Drug Administration (FDA) on the conduct of clinical trials for acute bacterial skin and skin structure infection (ABSSSI) has changed the framework for clinical trial design and conduct. Notable changes included new disease state definitions, new primary endpoint definitions and the timing of assessments at these endpoints, and updated guidance on patient inclusion/exclusion criteria. Supportive evidence and statistical justification for the proposed noninferiority margins were described in detail. Although the updated guidelines are still considered drafts and have been adopted in some trials, they serve as the basis for study protocol discussions between pharmaceutical companies and the FDA in advancing the development of promising new agents. Not only will the new trial designs impact researchers and sponsors responsible for drug development programs, but they will also affect healthcare providers participating in clinical trials and the ways in which clinicians develop patient treatment plans based on the results of those trials. This review provides a summary of key changes that will impact future clinical trial design and outcomes.
authors.affiliation: Department of Surgery, VA Boston Healthcare System, Boston University and Harvard University Schools of Medicine, Boston, Massachusetts.
authors.forename: Kamal M F
authors.initials: KM
authors.lastname: Itani
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Shorr
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D018579:Patient Selection; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000900:Anti-Bacterial Agents