Clinical trials are used to test the safety and effectiveness of drugs and devices. Usually, they are sponsored by pharmaceutical companies and conducted by research teams that include doctors and other medical professionals. Trials are typically conducted in four phases:
- During phase one, healthy people are given the medication to test if the ingestion of the pill or treatment has any adverse side effects.
- Phases two and three dive deeper into the safety, effectiveness and dosage of the medication. After these stages, the FDA will approve the drug or device.
- Phase four examines new uses for previously approved treatments.
All the phases in clinical trials are governed by strict protocols and overseen by many regulatory bodies, from the Food and Drug Administration (FDA) to small Institutional Review Boards (IRBs). IRBs are a group of independent medical experts, ethicists and lay people. Researchers report periodically to the IRB to share updates on the trial including contact with patients, the tests conducted and if any serious side effects have been reported. IRBs are accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). (Resource: https://www.policymed.com/2010/05/the-importance-of-clinical-trials.html)
To find a clinical trial near you and learn more, click here to visit SCDAA’s Clinical Trial Finder (created in partnership with Forma Therapeutics).