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Clinical trials enable health care providers to learn whether a new treatment is safe and effective. Drug and device clinical trials are classified as Phase 1, in which new formulations are tested for safety; Phase 2, in which the treatment is tested for effectiveness; or Phase 3, in which researchers look at both safety and effectiveness in a larger group of patients.

Only after a new drug or device passes all of the clinical trial phases is it then cleared by the FDA for general public use.

You will need to complete an informed consent form to participate in a clinical trial.

Before you sign an informed consent form, read it carefully. It should clearly outline both the possible benefits of the clinical trial and the known risks involved. If there is anything on the informed consent form that you do not understand, ask your physician about it before signing.

During your treatment in a clinical trial, you will be monitored and observed closely. If at any time during the trial, you or your doctor believes the treatment is not in your best interest to continue, you can leave or be removed from the study.

Although experimental treatment is usually free, there may be some costs to you or your insurer. Make sure that you discuss and understand the costs before you join any study.

If you think you may want to join a clinical trial, ask your physician if any study at Sharp may be appropriate for you. Your doctor should explain the criteria for trial eligibility — your health status — and the potential benefits and risks, such as side effects or other impacts on your health.

Sharp HealthCare's Outcomes Research Institute (ORI) has engaged in innovative, collaborative research to evaluate the long-term results of care, promote clinical excellence and advance best practices in health care delivery. Learn more about the ORI.