Use of Precision Medicine in Clinical Trials in Inflammatory Bowel Disease

The conventional drug development paradigm consists of a rigorous step-wise process that takes place over many years. Although this approach results in access to safe and effective new products, it is both costly and inefficient. Therefore, interest has emerged in clinical pharmacology, specifically an understanding of the inter- and intra-individual variability in pharmacokinetics and pharmacodynamics, to increase the efficiency of drug development in inflammatory bowel disease. A firm understanding of clinical pharmacology would benefit both drug development and clinical practice by allowing stratification of patients at baseline who would respond favorably to drugs with a certain mechanism of action and by identifying patients who may benefit from an accelerated dosing regimen or combination therapy. These principles are reviewed below.