Access

You are not currently logged in.

Access your personal account or get JSTOR access through your library or other institution:

login

Log in to your personal account or through your institution.

Statistical Aspects of Clinical Trials of Antibiotics in Acute Infections

Bernhard Huitfeldt
Reviews of Infectious Diseases
Vol. 8, Supplement 3. Evaluation of New β-Lactam Antibiotics (Jul. - Aug., 1986), pp. S350-S357
Published by: Oxford University Press
Stable URL: http://www.jstor.org/stable/4453929
Page Count: 8
  • Download ($42.00)
  • Subscribe ($19.50)
  • Cite this Item
Statistical Aspects of Clinical Trials of Antibiotics in Acute Infections
Preview not available

Abstract

Controlled clinical trials are important tools for evaluating antibiotics in acute infections. External and internal validity, definition of efficacy criteria, and size of the patient sample constitute special statistical problems in such studies. Critical issues regarding external validity pertain to the selection of patients and to the concept of consecutive patients. The internal validity of a study is influenced by the withdrawal of patients from the evaluation after randomization and the comparability of treatment groups with regard to prognostic factors. The definition of efficacy criteria on the basis of bacteriologic outcomes across control visits is not straightforward. Particularly, the evaluation of efficacy at the last follow-up visit must take into account the accumulated information rather than the cross-sectional information. The most common situation in comparative trials of antibiotics is that rather small differences in efficacy can be anticipated. Sometimes, the question at issue is the demonstration of antibiotic equivalence. For valid conclusions to be made in such situations, large samples must be used. A basic problem affecting many studies of antibiotics is that this criterion is not fulfilled.

Page Thumbnails

  • Thumbnail: Page 
S350
    S350
  • Thumbnail: Page 
S351
    S351
  • Thumbnail: Page 
S352
    S352
  • Thumbnail: Page 
S353
    S353
  • Thumbnail: Page 
S354
    S354
  • Thumbnail: Page 
S355
    S355
  • Thumbnail: Page 
S356
    S356
  • Thumbnail: Page 
S357
    S357