Phases of Clinical Trials
Healthy people volunteer to advance scientific knowledge and help others. People with certain illnesses volunteer to help find treatments for their specific condition.
In order to achieve FDA approval and be prescribed to patients, all new pharmaceuticals and devices must go through these four phases of clinical research trials:
Phase 1: This is the 'first in human' trial that primarily looks at safety and possible side-effects of the experimental medication/device.
Phase 2: Involves a slightly larger group of volunteers to further evaluate safety and actual effectiveness of the drug/device.
Phase 3: Involves an even larger group of volunteers to further confirm safety, effectiveness and other possible side-effects. The experimental drug/device may be tested against more standard treatments to prove effectiveness.
Phase 4: Often called "after-market studies," these are trials done after the drug/device has obtained FDA approval. They help to further identify effectiveness, safety issues, and side-effects in the general population.
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