Book excerpt: This volume is a comprehensive textbook for investigators entering the rapidly growing field of translational and experimental clinical research. The book offers detailed guidelines for designing and conducting a study and analyzing and reporting results and discusses key ethical and regulatory issues. Chapters address specific types of studies such as clinical experiments in small numbers of patients, pharmacokinetics and pharmacodynamics, and gene therapy and pharmacogenomic studies. A major section describes modern techniques of translational clinical research, including gene expression, identifying mutations and polymorphisms, cloning, transcriptional profiling, proteomics, cell and tissue imaging, tissue banking, evaluating substrate metabolism, and in vivo imaging.