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What Are Clinical Trials?
Medical researchers are always trying to develop better treatments, cures, medical devices, surgeries, and interventions. Clinical trials are how researchers determine things like safety, effectiveness, and proper dosage in humans. Researchers need volunteers of all different backgrounds, ages, ethnicities, and genders, either healthy or living with a particular condition, to participate in clinical trials. Diverse representation in clinical trials ensures that new treatments work for everyone.
Trials are broken down into four (4) phases:
- Phase I trials recruit a group of 20 to 100 healthy volunteers, or people with the disease/condition, to determine if the experimental treatment is safe to use on humans. Phase I typically lasts a couple of months. Approximately 70% of treatments move to Phase II.
- Phase II trials recruit up to 300 people with the disease/condition. While safety monitoring continues throughout all phases of clinical trials, Phase II trials focus on the effectiveness and side effects of the new treatment. Phase II can last several months to two years. Approximately 33% of treatments move to Phase III.
- Phase III trials continue to monitor safety, effectiveness, and side effects on thousands of volunteers. Phase III also focuses on how a drug works or reacts in combination with other drugs and monitors adverse reactions over time. At the end of Phase III, the FDA reviews the trial results and decides whether to approve or deny the experimental drug or device. Phase III typically lasts one to four years. Approximately 25% to 30% of treatments are FDA-approved and move on to Phase IV.
- Phase IV clinical trials happen after FDA approval. The FDA gathers information from several thousand volunteers who have the disease/condition and are using the new treatment after it has obtained FDA approval. This allows clinicians, researchers, and thousands of people with a disease/condition to report their experience and side effects from the treatment over decades. If you’ve taken any new medication, you may have been in a phase IV clinical trial and not even known it.
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