What is Clinical Research?

In its 1998 report, the NIH Director's Panel on Clinical Research stated that "clinical research" is:

a) patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes:

• Mechanisms of human disease

• Therapeutic interventions

• Clinical trials

• Development of new technologies

b) epidemiologic and behavioral studies, and

c) outcomes research and health services research.

Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. In other words, clinical or patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived.

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