Salvage therapy for aspergillosis

Abstract

Participants at the John E. Bennett Forum on Design of Clinical Trials for Fungal Infections suggested guidelines for the regulatory approval of drugs solely on the basis of salvage therapy-that is, the use of an unlicensed drug to treat patients who have experienced failure with or who have been intolerant of an approved drug. The topics covered included requirements for study design (i.e., the design allows the comparison of comparable items), entry criteria (in particular, the duration of therapy before salvage therapy is introduced), and outcome criteria that determine whether or not the treatment was successful.