DESCRIPTION OF CLINICAL TRIALS

Clinical trials are utilized to advance new treatments for a disease.   They offer patients a chance to partner with physicians to gain new knowledge about how to best treat a disease.  If a treatment is not yet approved by the FDA, clinical trials may be the only way for a patient to get access to the agent.  There are several different types of clinical trials:

Phase 1:  Testing the agent to find the best dose for future clinical trials.  A phase I trial helps define the side-effects of a drug.  Usually, less than 30 patients receive a treatment in the Phase 1 setting.  In a Phase 1 trial, every patient receives the experimental drug.

Phase 2:  Once the best dose of a drug is established in Phase 1 testing, the agent is tested in a particular disease to determine how effective it is.  Usually, less that 50 patients receive a treatment in the Phase 2 setting.  In a Phase 2 trial, every patient receives the experimental drug.

Phase 3: If a drug is thought to be an effective new treatment in the Phase 2 setting, it is tested against the standard of care treatment in a Phase 3 trial.  This usually requires a patient being randomized to the experimental treatment versus the standard of care. Usually, Phase 3 trials require more than 100 patients.