Clinical research studies (also called clinical trials) are done to test investigational drugs for diseases and conditions. Studies determine if investigational drugs are safe and effective. Before a medication can be approved by the FDA and made available to the general public, it has to go through several phases of clinical research. Most prescription medications that are used today are the result of past clinical studies.
Clinical study participation is completely voluntary. People participate in clinical research studies for a variety of reasons. Some volunteer to participate in studies because they want to learn more about their disease. Others volunteer because they want to help researchers learn more about a disease so that it may help others in the future. Participating in a study is an important personal decision that should be made after talking with your doctor and family members.
Clinical research studies follow a specific set of standards and are closely regulated. Precautions are put in place to protect people who participate in clinical research. Studies follow a written plan (protocol). The protocol describes the goals of the study, how the study is organized, and what doctors and participants will have to do during the study. Protocols and studies are reviewed by independent groups to evaluate whether the trials are safe and ethical. There are risks associated with clinical trials that the study doctor will discuss with you during the informed consent process.
A process called informed consent makes sure that you receive all the facts about the study and understand what will be involved if you choose to participate. During the informed consent process, the study doctor or staff explains the purpose of the study, length of the study, required office visits, tests and procedures, important contact information, and any known benefits and risks of the investigational study drug. You can ask questions at any time during the informed consent process or during the study. Before you can join a study, you will have to sign the informed consent document.
Yes. Even if you signed the informed consent document, you may leave a study at any time.
You should let your regular doctor know that you are involved in a clinical research study. You should also tell the study doctor if you are going to see another doctor and if any medication was prescribed during the visit.