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The widely used logistic regression may not be suitable to model binary outcomes in clinical trials. The present study compares and assesses various binary regression models such as logistic, log-binomial, Poisson and Cox proportional models for clinical trials. A dataset obtained from a clinical trial conducted on tuberculosis patients is used to illustrate the models. The estimated odds ratios from logistic regression severely overestimated the relative risks, thereby overestimating the overall relationship. Log-binomial and Poisson with sandwich covariance estimator were found to be suitable for estimating adjusted relative risks in clinical trials.

Keywords

Binary Outcomes, Clinical Trials, Regression Models, Relative Risk.
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