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Clinical trials are research studies conducted on new drugs or treatments in the
pharmaceutical industry to test if they are safe and effective for patients. A clinical
trial seeks to answer questions and find solutions to provide patients the safest, best
treatment for a disease or illness.
Clinical trials depend on people who volunteer to try a new drug or treatment. In
some cases, a drug has not yet been approved by the Food and Drug Administration (FDA)
to be sold in the United States. Or, the drug has been approved, but it is being tested
for a different treatment or additional information.
There are four different "phases" of clinical development:
- Phase 1: This type of trial involves a small group of people (20-80), and it is the first time a drug is tested in people. Researchers study whether the drug is safe and identify side effects and safe dosage amounts. This phase usually includes healthy volunteer subjects.
- Phase 2: This type of trial involves more people (100-300) than a Phase I trial, and it is typically is the first time the drug is tested in a patient population for which the drug is being developed. The primary purpose for this type of trial is to assess the drug’s effectiveness in the patient population for which it is intended. Researchers continue to study the drug’s safety
- Phase 3: During this phase of clinical development, trials usually involve a large group of people (1,000-3,000). Researchers evaluate how the patients are reacting to the drug – evaluating whether the drug is helping treat the patient as it should, monitoring additional side effects, comparing it to commonly used treatments and continuing to study ways for the drug to be used safely
- Phase 4: Commonly called post-marketing studies, this type of trial continues to focus on the drug’s safety, effectiveness and the best way the drug should be used.
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