Journal Article

Double-Blind Active-Control Trials: Beware the Comparator You Keep

Mark J. DiNubile

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue 8, pages 1064-1067
Published in print October 2008 | ISSN: 1058-4838
Published online October 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/592068
Double-Blind Active-Control Trials: Beware the Comparator You Keep

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

The indirect impact of the known comparator drug in double-blind comparative clinical trials of novel agents is underappreciated, despite its potentially pernicious effects. This hypothesis-generating analysis illustrates potential spillover effects of a comparator (amphotericin) in the evaluation of the first member (caspofungin) of a novel class (echinocandins) of antifungal drugs. Reported rates of drug-related fever in the first 3 studies of caspofungin for the treatment of mucosal candidiasis in patients with advanced human immunodeficiency virus infection were retrospectively analyzed. We compared patients who received 50 mg of caspofungin per day in a double-blind trial that used fluconazole as the comparator with patients who received the corresponding dosage in 2 similar earlier studies that used amphotericin as the comparator. With respect to the incidence of drug-related fever, the difference between the concurrent caspofungin and fluconazole groups was less than the difference between caspofungin groups from studies that used different comparators. In phase II/III blinded, active-control trials, the reporting of adverse experiences attributed to a first-in-class drug might be confounded to a variable degree by expectations regarding a well-known comparator.

Journal Article.  2614 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.