Randomization and efficiency in Zelen's single-consent design.
The "single-consent design" was devised by Zelen to circumvent the reluctance of some patients and physicians to participate in certain types of randomized clinical trials. Crucial to the validity of Zelen's design is randomized allocation of patients. Randomization theory is therefore the key theoretical base of the approach taken in this paper to an examination of the efficiency of this design.
Matts
J
J
Division of Biometry, School of Public Health, University of Minnesota, Minneapolis 55455.
McHugh
R
R
D000704:Analysis of Variance; D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D008962:Models, Theoretical; D011897:Random Allocation; D012107:Research Design