Abstract
When we compare an experimental treatment with the best standard therapy, Zelen first proposed use of the single-consent randomized design to increase the accrual rate of patients into trials. Under the single-consent randomized design, I developed two other simple test procedures to improve the power of the commonly used procedure for the intention-to-treat analysis in testing whether there is a difference in treatment effects in this article. Based on Monte Carlo simulation, I evaluated and compared these three test procedures with respect to type 1 error and power. I demonstrated that the two test procedures developed here outperformed the commonly employed test procedure in a variety of situations. Finally, I employed an example by studying the effect of vitamin A supplementation on reducing mortality in preschool children to illustrate the use of these test procedures.
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Lui, KJ. A Note on Hypothesis Test in Binary Data under the Single-Consent Randomized Design. Ther Innov Regul Sci 40, 219–227 (2006). https://doi.org/10.1177/009286150604000211
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DOI: https://doi.org/10.1177/009286150604000211