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Phases of a Clinical Trial
Clinical trials are conducted in distinct phases, each designed to answer specific questions about the new treatment.
Pre-clinical
The pre-clinical phase involves laboratory and animal testing to evaluate the basic safety, biological activity, and potential effectiveness of a new treatment before it is tested in humans.
Phase 1
Tests a new treatment in a small group of people to evaluate its safety, determine a safe dosage range, and identify potential side effects.
Phase 2
Expands the study to a larger group to assess the treatment's effectiveness and further evaluate its safety.
Phase 3
Involves large-scale testing to confirm effectiveness, monitor side effects, and compare the treatment to existing standard therapies.
Phase 4
Conducted after the treatment is approved, this phase tracks long-term effectiveness and monitors any rare or long-term side effects in a broader population.