Cancer Clinical Trials: What They Mean for You

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Cancer clinical trials aim to improve the outlook for people with cancer. These research studies are done in patients. They may test new cancer drugs (chemotherapies or targeted therapies), new surgical techniques, or new types of radiation therapy. They may study new ways to deliver treatment or new ways to combine treatments.

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Four phases of testing

Clinical research in cancer is done in four phases to answer different questions, explains Cleveland Clinic Taussig Cancer Institute oncologist Patrick Ma, MD, MS:

  • Phase I trials. These trials are the first step in testing a new cancer treatment in people. They explore the best way to give the treatment safely, and at what dosage.
  • Phase II trials. These trials determine whether a new cancer treatment works to halt or slow cancer growth and collects information about side effects.
  • Phase III trials. These trials compare the results of a new cancer treatment with the results of a standard cancer treatment in different groups of people.
  • Phase IV trials. After the treatment has been approved by the Food and Drug Administration (FDA) for use in patients, these trials address other questions. They may answer questions that come up during earlier phases, such as how a new treatment affects patients’ quality of life.

The pros of participation

When it comes to cancer, there are many advantages to participating in a clinical trial. You’ll receive high-quality cancer care. You may be among the first to get a promising new treatment. You’ll take an active role in a decision affecting your life, which can bring comfort during difficult times. Finally, you’ll also have a chance to improve the outlook for others with your particular cancer.

Consider the cons, too

It’s important to look squarely at potential drawbacks from participating in clinical cancer trials. New treatments are not always better than standard care. Unexpected side effects may happen and are sometimes worse than those of standard care. A new cancer treatment’s benefits may not apply to you.

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Finally, in randomized clinical trials comparing a new cancer treatment with standard care, you won’t know which treatment you are getting until the study is over to avoid bias. If you’re in the group receiving standard care instead of the new treatment, you won’t benefit from a new approach.

Translational research studies

These trials use tumor tissues removed during surgeries or biopsies as well as blood samples for laboratory studies. The goal is to improve cancer prevention, diagnosis and treatment in the future, says Dr. Ma. These “non-therapeutic” trials do not involve giving new cancer treatments to people, so typically the risks for participation are minimal. This is often called bench-to-bedside and bedside-to-bench research.

Decision time

So should you or your loved one participate in a clinical trial? Talk it over with a cancer specialist or cancer study nurse and your loved ones to come to the right decision. Don’t hesitate to ask the following questions:

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  1. What is the purpose of the study?
  2. What has previous research of this treatment shown?
  3. What is likely to happen in my case with treatment and without treatment?
  4. What are my options of treatment?
  5. What are the possible short- and long-term risks, side effects and benefits of the treatment?

You have a right to the answers. Our health literacy experts recommend writing questions down ahead of time and then writing down the answers at your visit. Studies show that stress interferes with our ability to think and remember information. And few things are as stressful as a health crisis.

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