Types of Clinical Trial Phases

Florida Cancer Specialists & Research Institute (FCS) continues to expand clinical trial opportunities for cancer patients close to home. More than 200 patients in Lee County participate in clinical studies each year — taking advantage of early access to the newest and most promising treatments available.

Critical to the development of new drugs and treatments, clinical trials occur in four specific phases to determine the risks, safety and effectiveness of new therapies compared to the current standard therapy.

Phase I

The primary goals of Phase 1 trials are to learn how a drug works in the human body, determine the maximum tolerated dose and the type and duration of any side effects.  They usually involve a small number of patients and the information gathered is used to begin Phase 2 trials.

Phase II

Phase 2 trials usually include larger numbers of patients than Phase 1 trials and are designed to assess the effectiveness of the treatment in a specific patient population. Drugs or therapies that show positive activity in this phase may be approved for standard treatment or may require additional evaluation in Phase 3 trials.

Phase III

A new drug or therapy is compared with a standard therapy in a randomized manner in Phase 3 trials.  These require a larger number of patients than earlier phase trials to measure the statistical strength of the results.

Phase IV

Once a drug or treatment becomes part of standard therapy, the drug’s manufacturer may initiate Phase 4 trials to further monitor and evaluate the effectiveness of the treatment and any side effects. Phase 4 trials are also conducted to evaluate a treatment’s usefulness in treating different types of cancers.

The FCS oncology care experts in Lee County are proud to play a key role in bringing more effective drugs to the marketplace through active participation in clinical trials.  We continue to encourage eligible patients to take part in clinical trials, so we can continue to improve overall cancer survivorship.  Talk with your provider to learn about the opportunities that may be available for you.