Understanding Clinical Trials
During clinical trials, researchers evaluate the safety and effectiveness of potential new treatments by monitoring their effects on groups of people. There are three primary phases to clinical trials:
Phase 1 trials determine the safety of a medicine by studying the effect on a small group (e.g., 20 to 100) of healthy volunteers.
Phase 2 trials test the medicine in a slightly larger group (e.g., 100 to 500) of volunteers who have the disease or condition the medicine is designed to treat. Phase 2 trials determine effectiveness, examine side effects and determine optimal dosing.
Phase 3 trials generate statistically significant information about the safety and efficacy of the medicine by enlisting a much larger group (e.g., 1,000 to 5,000) of participants.