Clinical pharmacology research is the process whereby medications are tested and approved for use in the treatment of various medical conditions. All medications must pass through prolonged, rigorous testing prior to their approval for prescription use in the U.S. population by the Food and Drug Adminstration. In order to obtain such approval, pharmaceutical companies ask physicians to recruit willing patients with medical conditions that are expected to respond to new medications. Hence, clinical pharmacology research offers patients the opportunity to experience the effects of new drugs prior to their release to the general public.

Clinical research is about finding the best way for patients to receive medical care. The NIH defines clinical research in three parts: a) patient-oriented (research involving interaction with human subjects), b) epidemiologic and behavioral, and c) outcomes and health services research. In each of these cases, researchers are looking to study how to improve health


Clinical trials progress in phases, moving toward use for patient care after the drug or device has been thoroughly studied for effectiveness and safety. The phases of clinical trials, which each new treatment must pass to be introduced into the market include:

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
(healthy volunteers)

Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical research includes clinical trials, which are studies that evaluate the effectiveness and safety of medical devices or drugs. These studies are conducted according to a formal protocol, which defines what kind of patient can participate, when and how much treatment is given, what is being measured, and the overall duration of the study.

Clinical Trials
Clinical Trial Phases
What is Clinical Research?

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