What is a Clinical Trial?
A clinical trial is a research study in human volunteers to answer specific health questions.
Carefully conducted clinical trials are the fastest and safest way to find treatments that work in
people and ways to improve health. Interventional trials determine whether experimental treatments
or new ways of using known therapies are safe and effective under controlled environments.
Observational trials address health issues in large groups of people or populations in natural
settings.
- Phase I Trials
Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side
effects associated with increasing doses, and to gain early evidence of effectiveness; may include
healthy participants and/or patients.
- Phase II Trials
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular
indication or indications in patients with the disease or condition under study and to determine
the common short-term side effects and risks.
- Phase III Trials
Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of
the drug has been obtained, and are intended to gather additional information to evaluate the
overall benefit-risk relationship of the drug and provide and adequate basis for physician
labeling.
- Phase IV Trials
Post-marketing studies to delineate additional information including the drug's risks, benefits,
and optimal use.
The preceding information is adapted from the glossary of ClinicalTrials.gov, a service of the National Institutes of Health.