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A Patient Guide to Clinical Trials

Clinical Trials Benefit Patients and Advance Therapies

When it comes to your health, exploring new frontiers may help you to find beneficial alternatives to traditional healthcare options. If you have vascular disease or heart disease that is not responding well to traditional treatment, for example, you may want to consider participating in a clinical trial.

Clinical trials are at the forefront of experimental healthcare therapies-but this type of research is far from a "Wild West" of new treatments. Though there are some unknowns involved, clinical research involves months, sometimes years, of extensive research and testing before studies are opened to human participants. New medical technologies must first show success through initial tests, in a lab or through animal studies for example, before a new approach can be used in a clinical trial.

Clinical trials are the last step in research that may begin with basic science and progress through many stages until the new therapy is ready for evaluation in humans. Every clinical trial in the U.S. must be approved by the Institutional Review Board and the Food and Drug Administration (FDA) before being offered to the general public. At BIDMC, clinical trials are also reviewed and monitored by the hospital's Clinical Trials Office, which has been nationally recognized for its clinical research management by the National Institutes of Health and other academic medical centers.

To learn more about clinical trials, HeartMail talked to Marc L. Schermerhorn, MD, a vascular surgeon at the CardioVascular Institute and Director of Vascular Surgery Clinical Trials at Beth Israel Deaconess Medical Center. He is currently involved with 12 active device trials-more than any other physician at BIDMC, a Harvard Medical School-affiliated academic institution that is a major participant in clinical trials.

What Are the Benefits of Clinical Trials?

Dr. Schermerhorn

Participating in well-executed trials enables eligible volunteers to gain access to the newest treatments while contributing to medical research. Some trials test a new drug or device, others study the use of standard treatments in a different way or for a different population, and some trials involve preventive measures or new diagnostic techniques.

"Clinical trials can provide a new option for patients when standard therapy cannot be used or has failed," said Schermerhorn. "For example, a recent clinical trial that we conducted involved the use of a new stent for people with diseased arteries in their legs. Standard surgery for superficial femoral artery (SFA) stents would involve large incisions and the use of several overlapping stents to open up blockages in the arteries. The new stents in the trial were more flexible and longer, which enabled a single stent to be inserted through a small incision."

Frank Romano, 78, was one of the patients to benefit from this BICMC trial. A retired machinist who lives in Revere, MA, Romano had carotid-artery surgery and an abdominal aneurysm in the past. Schermerhorn recommended his participation in the trial, knowing that Romano would avoid major surgery with the newly developed stent.

"The surgery went well, and I was home after three days," said Romano. "I feel healthier than I have in years, and I'm out walking and doing yard work. I would recommend getting involved with a clinical trial-especially if your doctor recommends it. It's a great way to benefit from the latest medical technology." The clinical trial of these SFA artery stents was successful-they have been approved by the FDA and are now available for medical use as needed.

What Are the Drawbacks?

It's important to note that not everyone who applies for a clinical trial is accepted. Each trial involves eligibility criteria, such as age, type and stage of disease, previous treatment history and other medical conditions, as well as limits on the number of participants.

A newly developed treatment in trial may take up more of the patient's time than standard treatments, since more tests, visits and follow-up may be required as part of the research.

Risks vary. "For some trials that involve an extension of existing technologies, the risk is minimal," explained Schermerhorn. "Trials that involve higher risk are offered to people who are in an extreme situation, perhaps facing an available treatment that would be equally as risky or considering the risk of taking no action at all."

How Does a Patient Find Clinical Trials?

At the CVI, Dr. Schermerhorn and his colleagues inform patients about current trials when clinically appropriate. They help patients weigh and compare the potential risks and benefits of the full range of therapeutic possibilities. Participation in trials is completely optional.

To learn more about current studies, you can contact the BIDMC Clinical Trials Office at 617-667-4443 or cto@bidmc.harvard.edu. Clinical trials.gov, a website maintained by the U.S. National Institutes of Health, maintains a databank of clinical trials easily narrowed down by region and health condition.

It's important to learn as much as possible about a clinical trial that interests or may apply to you. Be sure to discuss questions and concerns with a member of the trial-investigation team and with your physician. You'll want to know what happens during the trial and what type of healthcare you will receive before, during and after the trial. Participants must sign an informed-consent document beforehand that shows that they understand any risks that may be involved and are aware that they can leave the clinical trial at any time.

Though there may some inherent risks involved in participating in a clinical trial, keeping an open mind and taking the time to do a little research can help clear a new path to personal health benefits. People who participate in the trial can benefit from breakthroughs in healthcare while helping doctors and scientists to gain important knowledge that can impact the health of many individuals in the future.

Above content provided by Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.

Posted June 2011

Contact Information

CardioVascular Institute at
Beth Israel Deaconess Medical Center
330 Brookline Avenue
Boston, MA 02215
888-99-MYCVI
617-632-9777

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