Should I participate in a clinical trial or medical research?
Should I participate in a clinical trial or medical research?
Participating in a clinical trial may provide individuals first access to the newest drugs, treatments or disease management processes.
Learn more about the patient's role in medical research
What is a clinical trial?
Clinical trials include tests of new drugs or medical treatments in people to see if they are safe and if they work.
What happens in a trial?
Researchers create questions to answer and design a study plan, also 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 before beginning. They carefully monitor volunteers during the study and keep in touch after the study is complete.
Researchers check participants' health and give instructions before beginning. 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. These are to ensure that researchers will be able to answer the questions they plan to study and to keep participants safe.
Why should I enter 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 endanger your life. 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 treatment. There may be extra demands on your time and attention.
How will I be protected?
Before you decide to participate, you learn the key facts about a 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.
Also, independent review boards, such as the Allina Health Research Administration, approve and monitor all trials to make sure the risks are as low as possible, the trial is ethical and participants' rights are protected.
Also, independent review boards, such as the Allina Health Research Administration, approve and monitor all trials to make sure the risks are as low as possible, the trial is ethical and participants' rights are protected.
Questions patients should ask researchers
Asking questions such as these may help you decide whether to enter a clinical trial.
- What is the study trying to find out?
- Who put it together?
- Who is going to be in the study?
- Who will be in charge of my care?
- What exams, tests and treatments will I have?
- Will I need to be hospitalized?
- How much time will it take?
- How do the possible side effects, risks and benefits of the study treatment compare with my current treatment and other choices?
- How will I be protected from harm?
- How long will the study last?
- What follow-up is planned?
- Who will pay for the treatment and other expenses?
- How will my privacy be protected?
- Will I get the results?
Source: Coffey Communications; U.S. Department of Health and Human Services; Centers for Disease Control and Prevention; National Institutes of Health; U.S. Food and Drug Administration
Reviewed By: Timothy Sielaff, MD, PhD, FACS, president, Allina Health Cancer Institute
First Published: 08/17/2009
Last Reviewed: 08/17/2009