Participating in a Clinical Trial

Participating in a Clinical Trial

Kenneth J. Pienta, M.D., director of U-M's Michigan Institute for Clinical and Health Research, explains placebos are rarely used in cancer clinical trials.

Does being in a clinical trial require lots of office visits and tests?

It depends on the type of clinical trial. But it's true that most trial participants see their doctors more often, and have more blood draws, imaging scans and other tests than cancer patients on conventional treatment. The additional monitoring is important, because it protects the safety of patients enrolled in the study and shows whether the experimental treatment is working.

If I join a clinical study, how can I be sure I won't get a placebo?

A placebo, sometimes called a sugar pill, contains no medication. Because physicians today have conventional treatments for nearly every type of cancer, placebos are not used in clinical trials of experimental cancer treatments anymore. If you enroll in a cancer clinical trial today, you will receive either an experimental treatment, conventional treatment or some combination of experimental and conventional treatment.

 

Kenneth J. Pienta, M.D. and Denise Mouro, R.N. discuss what a "blinded" study is and that patients can withdraw from a clinical trial any time.

How can I be sure I get the experimental drug when I participate in a clinical study?

You can't. The purpose of a clinical trial is to find out whether an experimental drug works better than conventional treatment. To ensure valid results, most clinical trials are blinded so neither you nor your doctor will know which type of medicine you receive.

What if I decide I want out of the study?

You have the legal right to withdraw from a clinical trial at any time for any reason. If you decide to withdraw, you will continue to be treated at the U-M Cancer Center with the best conventional therapies available for your type of cancer.

Who pays for a clinical trial?

Clinical trials are sponsored by federal agencies like the National Institutes of Health or by private pharmaceutical or biotechnology firms. The costs of the clinical trial and the experimental therapy are covered by the sponsor. You and your insurance company are responsible for the cost of tests and procedures that are part of standard medical care. Before enrolling in a clinical trial, it is important to know exactly what will be covered by the trial's sponsor. Ask the doctor or nurse-practitioner in charge of the trial and check with your insurance company before you agree to volunteer.

Kenneth J. Pienta, M.D. discusses how important it is to make volunteering for a clinical trial easy and convenient. Without those patients willing to volunteer for a clinical trial, cancer treatment would not advance or improve.

If I join a clinical trial, will I have to stop seeing my community oncologist?

If you volunteer for a clinical trial at the U-M Comprehensive Cancer Center, your clinical care must be provided by U-M doctors who are responsible for patients enrolled in the trial or by their associates. However, if travel to Ann Arbor is a problem, U-M doctors may be able to arrange for routine tests to be performed by your community doctor.

Will I get paid for being a study volunteer?

That depends on the study's sponsor. Some clinical trials reimburse study volunteers for expenses involved in traveling to Ann Arbor, especially if it requires an overnight visit. Some studies offer a small stipend for the time and inconvenience involved in participating in the study. But many clinical studies provide no reimbursement for study participants.

If I join a clinical trial, what's in it for me?

No one can promise that an experimental treatment will cure your cancer, but it may prolong your life and give you more quality time to spend with your family and friends. Even if you don't receive any direct personal benefit, you will have the satisfaction of knowing that you've made an invaluable contribution to research. Many cancer patients who volunteer for clinical trials say they do it to help their children, grandchildren and others who may be diagnosed with cancer in the future.

Kenneth J. Pienta, M.D. discusses how important it is to make volunteering for a clinical trial easy and convenient. Without those patients willing to volunteer for a clinical trial, cancer treatment would not advance or improve.

Where can I find information about UMCCC clinical trials?

Start by asking your primary care doctor or oncologist about UMCCC clinical trials for your type of cancer. There are many sources of information about clinical trials on the Internet:

  • A U-M Web site called UMClinicalStudies.org includes a list of U-M clinical trials for many diseases and conditions and a place you can register to be contacted about future trials. Scroll down the list of diseases to find clinical trials related to cancer.
  • If you want to talk to a cancer nurse about your options, call the UMCCC's Cancer AnswerLine™ at 1-800-865-1125 or send them an e-mail message by accessing the Cancer AnswerLine™ web page.
  • For a list of Web sites with information about cancer clinical trials available at other locations, see our Resources webpage.

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