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2011 Informing Patients about Clinical Trials

Heart & Vascular Institute Physician eNewsletter - Fall 2011

Primary care physicians and referring cardiologists play a critical role in getting patients involved in important clinical trials. Patients trust them for information and guidance. And when patients can learn about trials for their condition long before they arrive at Cleveland Clinic for a procedure, they are more likely to consider enrolling.

"When a patient shows up at a major medical institution like Cleveland Clinic, they are totally unprepared for discussion about treatment options and especially randomized trials,"says Eugene Blackstone, MD, head of Clinical Investigations at the Sydell & Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic. "Plus, patients may not realize the benefits of participating, such as more frequent and interested follow-up of the patient's condition."

It's up to primary care doctors and referring cardiologists to plant the seeds of interest. But first, Dr. Blackstone maintains, physicians should understand the hurdles patients face when given the decision to choose a trial.

Before physicians can recommend Cleveland Clinic trials to their patients, they must understand exactly what these clinical trials entail. But there's a language barrier. Clinical trial descriptions, and even trial names (PARTNER, etc.), include complex terminology targeted to a researcher audience.

"Almost all the clinical trial informational materials are pitched toward patients—but they are written in terminology that patients find difficult to interpret," Dr. Blackstone says.

Cleveland Clinic is working to simplify the way clinical trials are defined and to answer questions in a simple FAQ format through

Physicians should be prepared to speak in plain language when answering patient questions, such as:

  1. What is the point of the trial?
  2. What does it cost?
  3. Who can join?
  4. What if I am not eligible?
  5. How can it benefit me?
  6. How is this different than the standard approach?

Understanding patient concerns will help physicians communicate more effectively the benefits of participating in clinical trials. Here, Dr. Blackstone notes common hurdles that prevent patients from participating, and what physicians can do to give patients resources to make an informed decision.

Speak their language. As a physician, get to know clinical trials that could be appropriate for your patients. Visit to find out what is offered at Cleveland Clinic and to read clear descriptions about what clinical trials entail. Then, translate this information in FAQ fashion to patients, Dr. Blackstone suggests.

Explain options early. "When patients arrive at Cleveland Clinic and are presented with an option to participate in a clinical trial, they are not prepared to make the decision because they haven't talked about it with their doctors or cardiologists at home," Dr. Blackstone says. That's why clinical trials should be introduced before patients arrive at the hospital for a scheduled procedure. Talk about clinical trials during office discussions and include them as treatment options. Also, present printed material for patients to take home and review with their families.

Sort out the real risks. Informed patient consent forms for clinical trials can read like a home mortgage. "They consist of pages of fine print including dangers and complications," Dr. Blackstone says. The information is overwhelming, and patients are confused about what risks really matter, he says. Help them understand what the key risks are out of the laundry list, and also discuss risks associated with standard treatment.

Tell them what they gain. There are many benefits to participating in clinical trials—emphasize those. Explain that patients who participate in clinical trials often experience excellent health outcomes—often better than if they were not in a trial. Talk about the large number of health care workers who will check patient data, and the rigorous follow-up that they might not otherwise receive.

Give them resources. The Internet is a vast, noisy universe and patients who are surfing for answers could be finding them from unreliable sources. Direct patients to, where they can learn about the benefits of participating in clinical trials and what to expect.

More Information
Reviewed: 09/11

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This information is provided by Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition.

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