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Definition of a Clinical Trial
The four phases of a clinical trial:
- The first experiment using an investigational new drug in
humans. (Designed to determine how the drug is broken down/interacts
with the human body.)
- Effectiveness studies of a drug in humans, researchers
administer the drug to participants, collect safety and
effectiveness data, study short-term side effects and risks, collect
information about the dose and schedule. (May involve control
groups.)
- Expanded, longer term studies performed after phase 1 and 2.
Intended to gather additional information about effectiveness and
safety needed to evaluate overall benefit/risk.
- Post marketing surveillance studies, to learn more about the
drug, gathering additional information about an approved drug’s
risks, benefits, best uses in real-life conditions. Trials of: doses
or schedules of administration, stages of the disease, cost studies,
quality-of-life studies, or use of drug over long period of time.
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