Studies performed in humans that are intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population.
Investigations aimed at translating basic, fundamental science into medical practice.
A carefully designed and executed investigation of the effects of a compound on human subjects. One goal is to determine efficacy of the compound.
Studies involving humans, and usually in the hospital or clinic settings, aimed at understanding the diagnosis or treatment of diseases and disorders.
Study of a drug, biologic, or device in human subjects
The testing of new treatments in humans to determine their results.
Testing a new Treatment in humans.
Patient-oriented research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, epidemiologic or behavioral studies, outcomes or health services research, or developing new technologies, therapeutic interventions, or clinical trials.
Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. Also called clinical study and clinical investigation. Note that in this manual, this term is used in its narrow sense as used by the FDA. Thus, it does not encompass all the research that is carried out in the clinical setting (e.g., health services research).
Treatments with the most promising laboratory results move from laboratory and animal studies into the clinical trial stage. In clinical trials, scientists apply their discoveries to humans, testing new drugs, devices, or innovative therapies in selected patients. Carefully conducted clinical trials are the safest way to evaluate potential medical treatments, assessing their effectiveness and potential risks.
deals with the study of human subjects. Attempts to determine whether the findings of basic research are applicable to humans.
Involving or concerned with the direct observation and treatment of living patients vs. theoretical science. Evaluating the safety and effectiveness of new drugs or therapies by monitoring their effects on people.