19 , 000 Medicines, 100 Medical devices, Vaccines,
In a clinical trial, doctors and other sta give treatments to volunteers based on a specific plan. Experts review this plan to make sure volunteers are safe. volunteers
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.
volunteers in clinical trials worldwide in 2015 131 , 749 40 , 835 of those volunteers were in the U.S.
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.
Phases allow careful testing of new possible treatments. Each phase answers di erent and important questions.
Phase 1
Phase 2
Phase 3
Phase 4
of volunteers 1000s
100s of volunteers
10s of volunteers
Countless volunteers
FDA Approval
Is it safe for people? How much of the treatment is needed?
Does it work better than the current treatment? Are there new safety concerns?
Does it work for all types of people? Are there new safety concerns?
How well does it work? Are there new safety concerns?
www.fda.gov/AboutFDA/Transparency/ Sources: www.fda.gov/downloads/Drugs/InformationOnDrugs/
Interested in volunteering for a clinical trial? Visit: www.melanoma.org/clinical-trials
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