Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods

11.5 Summary

Clinical researchers face increasing challenges and are presented with unique opportunities in the new era of personalized/precision medicine to meet the needs of patients, payers, and the ever increasing costs of health economics. In this chapter, we gave an overview of population enrichment designs that are growing in the statistical literature, with a focus on designs of predictive enrichment strategies so as to increase the power and efficiency to detect an effective therapy with regard to a predictive biomarker in a clinical trial. We categorized the existing designs into classical designs, frequentist adaptive designs, and Bayesian adaptive designs. We also discussed the efficiency of a biomarker enrichment design compared ...