Year: 2005
Type: article
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.
Source: Clinical Infectious Diseases
DOI: 10.1086/430921
Author: John E. Bennett
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,763
OpenAlex ID: W2108190467
