The Basics
Written by the doctors and editors at UpToDate
What is a clinical trial? " A clinical trial is a research study that uses people to find new ways to improve health. People volunteer to be in clinical trials. Clinical trials can:
- Test new treatments to see if they help with certain diseases or conditions better than the current treatments
- Test treatments or lifestyle changes to see if they prevent or lower the chance of getting certain diseases
- Test new ways of finding out if people have certain diseases
Clinical trials that test new treatments, such as medicines, fall into 1 of 3 types. The type of trial depends on its goal and how much testing the treatment has already had. The different types of treatment trials are:
- Phase 1 (I) trials " In phase I trials, doctors check the safety of a new treatment. They learn how the medicine should be given, how often it should be given, what dose is safe, and what the side effects are.
- Phase 2 (II) trials " In phase II trials, doctors give a new treatment to a group of people with a certain disease. The doctors check the treatments side effects and how well it works to treat the disease.
- Phase 3 (III) trials " In phase III trials, doctors compare a new treatment with the current treatment for a certain disease. They learn if the new treatment helps the disease better, worse, or the same as the current treatment. They also learn if the new treatment has more or fewer side effects than the current treatment.
Who can be in a clinical trial? " It depends on the trial. Some trials (usually phase II or III trials) use only people with certain diseases or conditions, or whose family members have certain diseases or conditions. Other trials use people who are healthy, instead of people with a certain disease or condition.
Not everyone who wants to be in a trial can be in 1. To be in a trial, you need to meet certain conditions. Often, you need to have the disease or problem being studied. Other conditions usually have to do with the health of your heart, liver, kidneys, or other organs. To see if you meet the conditions, you might need to answer questions or have an exam or tests.
What are the benefits of being in a clinical trial? " People can benefit in different ways. People who have the disease being studied can benefit by:
- Having a chance to get a new treatment before it is available to the public
- Having expert doctors treat them and follow their disease closely
- Knowing that they are helping people who will have their disease in the future
Healthy volunteers can benefit from being in clinical trials, too, by:
- Knowing that they are helping others
- Learning about their health and about research
What are the downsides of being in a clinical trial? " The downsides can include the following:
- The new treatment can have side effects. The side effects might be unknown or unexpected.
- The new treatment might not work as well as the current treatment, or it might not work at all.
- You might not get the new treatment " Some studies (such as phase III trials) compare a new treatment with the "usual " treatment for a disease. Other studies compare a new treatment with a "placebo " (sugar pill). A placebo is a treatment that looks the same as medicine and is given the same way, but doesn't have any medicine in it. A placebo is used only if doctors aren't sure that the usual treatment helps or if there isn't any good treatment for that disease or condition. In general, in studies that compare 2 treatments, half of the people get the new treatment, and the other half get the usual treatment or placebo. Neither you nor your doctor can choose which treatment you get. Also, in many cases, you won't know which treatment you got until the trial is over.
What else should I know about clinical trials? " You should know that:
- It's your decision to be in a trial or not. To help you decide, the doctor will talk with you and answer your questions. He or she will tell you about the trial, the benefits and downsides, and the tests and treatments you will have. If you agree to be in the trial, you will need to sign a consent form.
- Experts check all trials " before and during them " to make sure that they are safe for people to be in.
- You will not have to pay to be in a trial. But your insurance might be billed for some of the treatments or tests that you have during it.
- During the trial, you will need to follow all of the instructions about visits, tests, and treatments. If you have any side effects or problems, let the doctor know.
How can I find out about getting in a clinical trial? " To search for clinical trials in the United States and worldwide, check the National Institutes of Health (NIH) Web site (www.clinicaltrials.gov). If you have a disease, you can also talk with your doctor or nurse. He or she might know of a clinical trial looking for people with your disease. If you have cancer, you can search for clinical trials on the National Cancer Institute Web site (www.cancer.gov/clinicaltrials).
All topics are updated as new evidence becomes available and our peer review process is complete.
This topic retrieved from UpToDate on: Nov 04, 2014.
Topic 16168 Version 6.0
Release: 22.8 - C22.206
© 2014 UpToDate, Inc. All rights reserved.
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© 2014 UpToDate, Inc. All rights reserved.