Clinical Trials Homepage 12 Answers to Common Questions Is a Clinical Trial Right for You? Benefits and Risks Your Rights and Informed Consent Concerns for Women, Children and Genetic Privacy 10 Questions to Ask Fact or Fiction? Take the Quiz What to Expect in a Clinical Trial Glossary

Benefits

People participate in a clinical trial for many reasons. Healthy people may join clinical trials to contribute to medical science and improve medical knowledge and care for others. Clinical trials also may provide free medical care during the trial, which appeals to some people.

If you have a specific illness, clinical trials offer access to new approaches that are often not available otherwise. Here are some of the benefits cited by the National Institutes of Health (NIH), which funds many clinical trials:

• The approach being studied may be more effective or safer than the standard approach.
• Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.
• Participants may be the first to receive the new method under study.
• Results from the study may help others in the future.

Risks

You should understand that clinical trials are still experiments. They involve risks. Here are some of the risks the NIH urges you to consider before joining a clinical trial.

• New drugs or procedures under study are not always better -- and could be worse -- than the standard care to which they are being compared.
• New treatments may have side effects that doctors do not expect. Sometimes these side effects are permanent.
• Participants in randomized trials will not be able to choose the approach they receive.
• Health insurance and managed care providers may not cover all patient care costs in a study.
• Participants may be required to make more visits and undergo more procedures than they would if they were not in the clinical trial.

Safeguards

By federal law, researchers must take several steps to make clinical trials as safe as possible. These include:

• A written examination about the content of clinical research and ethical responsibilities of researchers.
• Preclinical studies that show that a new treatment is safe and effective in laboratory and animal tests.
• Use of a strict protocol -- an outline prepared before the beginning of a study that describes exactly what will take place during the trial.
• A written description of all the information that you will need to make an informed decision about joining a clinical trial. The process of giving you this information is called informed consent.
• Approval of the trial by an Institutional Review Board (IRB) -- a group of at least five doctors, statistical experts, and selected non-medical community members. An IRB must approve all clinical trials before they begin and at least once ever year afterward. The IRB evaluates the merits of a trial and ensures that the clinical trial poses no unnecessary or inappropriate risks.

Before you make a decision about joining a clinical trial, make sure you understand every aspect of your participation in the experiment. This includes what side effects you might expect, how much time and effort the trial will take, and whom you should contact if you have any problems.

If You Are Harmed

Researchers must tell you who will pay for treatment if you are injured in a research study. The federal government requires that researchers provide this information in the informed consent document.

Sponsors of clinical trials may deal with research-related injuries in different ways:

• Reimburse all medical expenses from all research-related injuries.
• Reimburse medical expenses that are not covered by your medical insurance policy.
• Reimburse some or all medical expenses, but only after they are reviewed individually.

These examples are obviously very different. You should work hard to understand your options before you enroll in a clinical trial.

Published December 2002.

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