Author:

Bennett JE

Date: 18 October 2005

Abstract:

Participants at the John E. Bennett Forum on Design of Clinical Trials for Fungal Infections suggested guidelinesfor the regulatory approval of drugs solely on the basis of salvage therapy—that is, the use of an unlicenseddrug 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 comparableitems), entry criteria (in particular, the duration of therapy before salvage therapy is introduced), and outcomecriteria that determine whether or not the treatment was successful.

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