A clinical trial (also called clinical research) is an investigational drug or device research study in human participants to answer specific health questions. Carefully conducted clinical trials are the safest way to confirm that treatments work and improve health.
Participants in clinical trials can play a more active role in their own health care. They may gain access to new research treatments before they are widely available, and may help others by contributing to medical research.
All clinical trials have guidelines about who can participate based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and study staff involved in the trial review the study details as outlined in the Informed Consent with the potential participant.
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team.
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.