Clinical Research Studies: General Information

Clinical research studies, also known as clinical trials, are scientific studies in which people help doctors find ways to improve health and health care. Many of today's treatments for illness are based on the results of past clinical trials. At the Dental School, University of Maryland, Baltimore (UMB), clinical research studies are sponsored by the National Institutes of Health (NIH) or by pharmaceutical companies. The NIH has developed a Clinical Trials consumer-friendly database to provide patients, family members, and members of the public current information about clinical research studies, and most pharmaceutical companies have web sites that provide information to the public about their current research studies.

Clinical research studies enroll people who are alike in certain ways, depending on the study's purpose. The study's protocol tells who can join the study and spells out the characteristics that people should have. These are called eligibility criteria. They may include age, gender, general health, and risk factors.

Eligibility criteria are a key part of medical research. They help produce results we can trust. And after those results are known, the information can help doctors find out who will be helped by the approach being studied if it's shown to work. For example, a new drug might not work for people with one type of risk factor, or it may work better for men than for women.

Eligibility criteria also help protect you. They help make sure that if you are likely to be harmed by something in the study, you are not exposed to that risk.

Testing in humans is permitted only if a person volunteers for participation. The person is informed of all the risks and benefits of taking part in the study, including details about the study approach and any tests that may be performed. When a person decides to participate, he or she signs a consent form. This process is called informed consent, and it lasts as long as the person is in the study. In other words, a volunteer can change his or her mind and leave a study at any time.