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What Are the Possible Benefits and Risks of Clinical Trials?

Possible Benefits

Taking part in a clinical trial can have many benefits. For example, you may gain access to new treatments before they're widely available. If a new treatment is proven to work and you're in the group getting it, you might be among the first to benefit.

If you're in a clinical trial and don't get the new strategy being tested, you may receive the current standard care for your condition. This treatment might be as good as, or better than, the new approach. You also will have the support of a team of health care providers, who will likely monitor your health closely.

In late-phase clinical trials, possible benefits or risks of a treatment can be identified earlier than they would be in general medical practice. This is because late-phase trials have large groups of similar patients taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards.

Even if you don't directly benefit from the results of the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because they want to help others.

Possible Risks

Clinical trials do have risks and some down sides. For example:

  • The new strategies and treatments being studied aren't always better than current standard care.
  • Even if a new approach benefits some participants, it may not work for you.
  • A new treatment may have side effects or risks that doctors don't know about or expect. This is especially true during phase I and phase II clinical trials. The risk of side effects might be even greater for trials with cutting-edge approaches, such as gene therapy or new biological treatments.
  • Health insurance and health care providers don't always cover all patient care costs for clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage.

You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?"

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Clinical Trials

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.

 
August 03, 2012 Last Updated Icon

The NHLBI updates Health Topics articles on a biennial cycle based on a thorough review of research findings and new literature. The articles also are updated as needed if important new research is published. The date on each Health Topics article reflects when the content was originally posted or last revised.

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