What are clinical trials? In 1962, the U.S. government passed a law that required the Food and Drug Administration (FDA) to test all new treatments to show
they work (are effective) and are safe for people to use. These tests are called clinical trials. Since then, the FDA has approved more than:
23K Medicines, such as for high blood pressure.
7.0K Medical devices, such as pacemakers.
111 Vaccines, such as the flu shot.
Researchers must give volunteers complete information about the clinical trial before they agree to take part. This is called informed consent. Volunteers can leave the trial at any time.
Clinical trials rely on volunteers to study new treatments In a clinical trial, doctors and other staff give treatments to volunteers based on a specific plan. Experts review this plan to make sure volunteers are safe. 44,000 volunteers participated in clinical trials in 2023.
48% Female
52% Male
Clinical trials take place all over the nation and are sponsored by many types of organizations, such as the government, hospitals, drug companies, and research centers.
Clinical trials move in phases to ensure safety and effectiveness
Phases allow careful testing of new possible treatments. Each phase answers different and important questions.
Phase 1 (Months)
Phase 2 (Months to 2 years)
Phase 3 (1 to 4 years)
Phase 4 (Many years)
10s of volunteers
100s of volunteers
1,000s of volunteers
Countless volunteers
FDA Approval (Months)
Questions to answer: • Is it safe for people? • How much of the treatment is needed?
Questions to answer: • How well does it work? • Are there new safety concerns?
Questions to answer: • Does it work better than the current treatment? • Are there new safety concerns?
Questions to answer: • Does it work for all types of people? • Are there new safety concerns?
Sources: • https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states • https://www.fda.gov/economics-staff/fda-glance • https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
Interested in volunteering for a clinical trial? Visit: www.melanoma.org/clinical-trials
LAST UPDATED 3/2025
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