ABSTRACT

By clinical research I mean the performance on human subjects of experimental procedures, trials and tests, usually of a therapeutic nature, with new drugs or new applications of older drugs. The term also encompasses the performance of purely physiological tests on humans, to find out either how drugs work or how humans work. A clinical investigator is someone who performs such experiments: he is usually a qualified physician or sometimes a dentist, or if he is scientifically qualified but has no specific medical training, he works very closely with a medical practitioner who provides ‘medical cover’. Most drug regulatory authorities prefer their investigators to be medically qualified.