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NMMC Cancer Research & Clinical Trials

After a new treatment has been carefully studied in the laboratory, it’s then studied in human subjects. The four phases to clinical research are:


Phase 1 - Trial participants are typically healthy individuals, although for oncology, the first trials in human participants are patients with the disease that the experimental medicine is intended to treat. Phase I studies are the core of drug development. Their purpose is to find a safe dose; decide how the new treatment should be given (by mouth, in a vein, etc.)and to see how the new treatment affects the human body.


Phase 2 - If a new treatment is found to be reasonably safe in phase I clinical trials, the treatment can then move to phase II research to see if it works the way researchers think it will. The purpose of this phase is to determine if the new treatment has an effect on cancer. Along with watching for responses, the research team keeps looking for any side effects. Less common side effects may be seen. Still, about 70% of phase II cancer drugs don’t advance to phase III, usually because they don’t work well enough.


Phase 3 - If enough patients benefit from the treatment, and the side effects aren’t too bad, the treatment is allowed to go on to a phase III clinical trial. The goal of this phase is to compare the new treatment with the current standard of care for that specific disease.


Phase 4 - post-marketing populations with the disease or condition (more variety in gender, age and race)


Each phase involves a greater number of human subjects, and the new treatment is thoroughly evaluated before it progresses to the next phase. FDA officials use this information when they consider approving the drug for general use.


Numerous national research trials (phase 2, 3 and 4) are being conducted locally. Participating in a clinical trial gives patients access to treatment that may not otherwise be available. It also gives them a chance to help others by contributing to research and advancing the current standard of care in the disease that they fight.


For more information on clinical trials at NMMC, call (662) 377-3888.