Clinical Trials

Clinical trials are experiments conducted on human subjects or animals in the process of developing new medical treatments, devices, and procedures. The results of a clinical trial are usually part of a package that supports the developer’s a priori stated claim that the proposed treatment has a beneficial effect of a specified kind and for a specified condition. Clinical trials are characterised by the intent to adhere to the principles of experimental design and to ensure that the exposure of vulnerable subjects (humans or animals) to experimentation is as small as possible, and yet sufficient for collecting evidence related to the claim. After setting out the context in which clinical trials are conducted, this chapter discusses the established methods for their design and analysis and then presents some alternatives.