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

11.4 Adaptive Enrichment Designs

11.4.1 Introduction

It has been well recognized and documented that increased spending in pharmaceutical and biotech research does not reflect an increase of the success rate of clinical development. Woodcock [26] outlined some of the reasons for the declining success rate of pharmaceutical development namely (i) high bar for proving drug benefits due to diminished margin for improvement, (ii) increased costs and complexity potentially decreasing the ability to bring many candidates forward into the clinic, (iii) genomics and related disciplines are not yet fully developed, (iv) chronic diseases are harder for the study sponsor to choose easy targets for investigation and investment. The United States Food and ...