Clinical Research Study Process

Phase I

• First studies of new treatments in humans – safety tests
• Involve a small number of healthy volunteers
• Drug dosages are monitored for safety, drug absorption, and how the drug is metabolized and excreted
• Studies are short

Phase II

• First efficacy and safety studies
• Study patients are participants with a diagnosed disease for which the drug is intended
• Drug is studied for safety and its potential effectiveness in treating the disease
• Studies are longer

Phase III

• Comparison studies: to test one treatment vs. another
• Study patients are participants with a diagnosed disease for which the drug is intended
• The current standard of care drug is compared to the study drug
• Final phase of testing for a new drug to be submitted to the FDA for approval
• Larger scale studies to confirm efficacy and safety

Phase IV

• Studies of already FDA approved drugs for new indications and/or doses

Clinical Studies Contact Us