Randomized consent designs for clinical trials: An update
Article first published online: 12 OCT 2006
Copyright © 1990 John Wiley & Sons, Ltd.
Statistics in Medicine
Volume 9, Issue 6, pages 645–656, June 1990
How to Cite
Zelen, M. (1990), Randomized consent designs for clinical trials: An update. Statist. Med., 9: 645–656. doi: 10.1002/sim.4780090611
- Issue published online: 12 OCT 2006
- Article first published online: 12 OCT 2006
- Public Health Service
- National Cancer Institute, National Institutes of Health. Grant Number: CA-23415
- Department of Health and Human Services
Randomized consent designs were introduced to make it easier for physicians to enter patients in randomized clinical trials. Physician reluctance to participate in randomized clinical trials is often a reflection that the physician-patient relationship could be compromised if the physician makes known to the patient his/her inability to select a preferred therapy. Clinical trials having a no-treatment control or placebo amplify this concern. This paper reviews the main ideas of randomized consent designs (single and double) and the statistical model underlying the analysis, and presents some recent experiences.