Understanding the patient’s role in medical research and clinical trials
Participating in a clinical trial may provide individuals first access to the newest drugs, treatments or disease intervention. Learn more about participating in medical research with the information below.
What is a clinical trial?
Clinical trials include tests of new drugs or medical treatments in human subjects to see if they are safe and if they work.
How does a clinical trial work?
Researchers devise questions to answer and design a study plan, which is called a protocol. It outlines who may participate, what tests, procedures, or medications they will get, and how long the trial will last.Researchers check participants’ health and give instructions at the onset. They carefully monitor volunteers during the study and keep in touch after the study is complete.
Who can participate?
Volunteers must meet certain criteria based on factors such as age, gender, and health status. The criterion is utilized to ensure that researchers will be able to answer the questions they plan to study and to keep participants safe.
Why should I consider participating in a clinical trial?
You can take a more active role in your health care, gain early access to new drugs and treatments, obtain expert medical care, and help others by contributing to medical research.
What are the risks?
Risks vary based on the study. It is very important that you discuss them with your doctor. Side effects may be unpleasant, serious, or even life threatening. Some may be unexpected or appear after treatment ends. The treatment may not work, or you may be in a placebo group that gets no active treatment. There may also be extra demands on your time and attention.
How am I protected?
Before you decide to participate, you will learn the key facts about the trial through a process called informed consent. Then you sign an informed consent document. The informed consent is not a contract; you can leave the study at any time, for any reason. Throughout the study you will be provided any additional information.Also, independent review boards approve and monitor all trials to make sure the risks are as low as possible, ethical, and that the participants’ rights are protected.