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

6.1 Introduction

In the drug development process, a candidate compound needs to go through a stringent series of testing for toxicity, pharmacokinetics/pharmacodynamics, efficacy, and safety before it can be released to the market for patient use. The process involves different phases of nonclinical studies on animals and clinical studies in healthy volunteers and in the targeted patient population with the disease [1, 2]. Clinical studies can be categorized into 4 phases (phase I-IV), corresponding to four levels of stage-gate drug development: human pharmacology, therapeutic exploratory, therapeutic confirmatory, and therapeutic use studies [3]. Phases I and II are generally considered exploratory and learning phases. The goal of phase III ...