A clinical trial is a research study designed to answer specific health questions related to the development, production and evaluation of the effectiveness of new treatments and therapies for diseases. Clinical trials rely on human volunteers to carefully and safely evaluate new treatment options and ways to improve health in a controlled setting. Clinical trials test the benefits of experimental treatments, new medications, combinations of existing drugs and new ways of using known therapies. These tests use the most advanced drug therapies available. If a trial proves successful, the treatment may become a standard practice.
For additional information on clinical trials, visit clinicaltrials.gov/ct/info/resources.
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.
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.