Should You Volunteer to Try a New Therapy?

What you should know about clinical trials

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If you have a condition that is difficult to treat, your doctor might offer to enroll you into a clinical trial of a new therapy. Should you accept?

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Before making this decision, it’s important to understand that clinical trials look at new ways to prevent, detect or treat disease. They are research studies done in patients that may test new drugs, new surgical techniques or new types of therapy. They may study new ways to deliver treatment or new ways to combine treatments.

Questions you might ask before deciding to volunteer for a clinical trial include: What new treatments will be available to me through this clinical trial? What are the advantages and disadvantages of participating?

Another consideration I share with patients is the fast pace of medical research. The new discoveries I see about the causes and natural history of diseases take my breath away. After practicing medicine for more than 30 years, I’ve witnessed ever-increasing medical advances as innovative treatments emerge. Before these treatments can be readily developed and prescribed, they must be extensively studied in humans to receive approval by the U.S. Food and Drug Administration (FDA). This happens through clinical trials.

The only types of studies that the FDA considers are called “randomized” clinical trials, which means that patients are assigned to the new treatment or placebo (inactive therapy) by the luck of the draw. Neither you nor your doctor will know what treatment your are getting to make sure that the research results will be unbiased.

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Interestingly, for many trials, 30 percent or more of placebo-treated patients improve. That, in itself, is quite interesting.  There have been whole books written about trying to understand the “placebo effect.”

Advantages and disadvantages of participating in a randomized clinical trial are important to consider.

Advantages

  1. Access to a medication that could be better than your current therapy
  2. Repeated comprehensive evaluations by study nurses and laboratory testing (you will be watched like a hawk)
  3. Free healthcare related to the study, including free medication

Disadvantages

  1. Possibility of having side effects that were may or may not have been predicted by the animal studies and preliminary human studies
  2. Chance of receiving placebo (inactive therapy)
  3. Requirement to agree to all of the specifics of the study, like taking medications, showing up for appointments, or even using specific types of contraception

Before initiating a study at Cleveland Clinic, the investigator needs to have the study approved by a group of doctors and community leaders which make up the Cleveland Clinic Institutional Review Board (IRB). This board protects you and other patients by making certain that the risks of therapy for every clinical trial are acceptable and much lower than the potential benefits.

As a patient enrolled in any clinical study, you would need to fully understand:

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  • The risks and benefits of the study drug
  • The requirements of the study protocol

You would also need to sign an informed consent document. You should never sign an informed consent document until you really understand the details of the study and have had a chance to ask all the questions you have.

If you choose to participate in a clinical trial, you may be helping yourself, but you may also be helping future patients with similar problems.

Many investigators in clinical trials are gastroenterologists at Cleveland Clinic, and I join them in saying that when approved treatments no longer can help patients, being able to offer innovative therapies is important.

Learn about clinical trials in the Digestive Disease Institute

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Bret Lashner, MD

Bret Lashner, MD, is a gastroenterologist, Director of the Center for Inflammatory Bowel Disease and a Professor of Medicine at Cleveland Clinic.