Clinical trial protocols are the guidelines that must be followed during the course of any clinical study. For patient safety, each protocol must be approved by the organization that sponsors the study and the Institutional Board (IRB) at the hospital. The IRB, which includes community members, clergy and health professionals, reviews the protocol to try to be sure that the research will not expose patients to extreme or unethical risks.

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.

• Phase I Trials: Researchers test an experimental drug or treatment on a small group of people (20-80) for the first time to evaluate its safety, how it should be administered (orally, intravenously or by injection) and how often. These trials also help healthcare professionals determine a safe dosage range and identify side effects.
• Phase II Trials: The experimental drug or treatment is gen to a larger group of people (100-300) to provide preliminary information about how well the new drug works and to generate more information about its safety and benefits.
• Phase III Trials: The experimental drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly-used treatments and collect information that will allow the experimental drug or treatment to be used safely.
• Phase IV Trial: Continued evaluation takes place after FDA approval, when the drug is already on the market and available for general use.

Each protocol in a clinical trial has specific characteristics, called eligibility criteria that participants should have in order to participate in the study. Characteristics may include type of disease and its stage, the participant’s age and general health.

Eligibility criteria help assure that the study results answer the research questions at hand and identify who will benefit in the future from the approach being studied.

As you consider enrolling in a clinical trial, you will want to review your insurance coverage. Even if you have health insurance, your coverage may not include some or all of the patient care costs associated with a clinical trial. This is because some health plans define critical trials as “experimental” or “investigational” procedures. As a result, we suggest you contact your insurance provider for more details.

In 2000, Medicare began covering beneficiaries’ patient care costs in clinical trials. Up-to-date information about what Medicare will cover can be found on the Web site of Centers for Medicare & Medicaid (formerly the Health Care Financing Administration).

For additional information on clinical trials, visit clinicaltrials.gov/ct/info/resources.