An Introduction to Clinical Research Concepts

This chapter provides a bird’s eye view of the glossary of clinical research, which is concerned with humans as subjects (or just their clinical data). I introduce the “level of evidence” hierarchy and provide a very basic tutorial of statistics in clinical research. I then discuss the individual stages in the evaluation of investigational therapies before they are permitted to be introduced into the market. I also consider why established therapies must often be reinvestigated, as well as the methods for doing so. I focus specifically on the methods employed for comparative-effectiveness studies: patient randomization, crossover design for chronic conditions, and double-blind designs. I then provide a basic introduction to pragmatic clinical trials. I discuss the evaluation of medical software, which in most cases is treated as a medical device.