Clinical Trials 101: What You Need to Know

Clinical trials are medical research studies involving real people. These studies typically involve experimental medication and treatments alone or in combination with already FDA approved medications, targeting various diseases. Clinical trials are a primary way of advancing science and medicine forward.

So how do you know if a clinical trial might be right for you? And what is the process to participate?

Healthy State talked with some experts at Lahey Hospital & Medical Center to learn more about five questions asked when it comes to clinical trials.

1. What are some common misconceptions a patient has regarding clinical trials?

“A common misconception we see is patients thinking that clinical trials are only recommended to people who have run out of options,” said Dr. Corrine Zarwan, an oncologist and Director of Clinical Research for the Lahey Health Cancer Institute. “In reality there are many clinical trials for newly diagnosed cancer patients. There are even trials for those who do not have cancer but are at higher risk of developing it.”

Another common misconception is that all clinical trials contain a placebo, or a pill that has no therapeutic effect. Of course, some studies employ the use of placebos, but this is always clearly stated in the consent form for the study.

Typically patients who are on placebo are still receiving the standard of care, Dr. Zarwan explained. Everyone on the trial may be getting one standard of care treatment, but some patients will also additionally get the experimental drug.

2. How do you know if you’re a candidate for a clinical trial?

Some patients ask about studies, but not all are aware of the many active trials going on at our hospitals (there is anywhere from 50 to 100 active trials at Lahey’s hospitals). In the offices of the Cancer Institute, Dr. Zarwan said, there are signs posted to increase awareness of the clinical trials. If a patient fits the criteria for an ongoing and open study, usually the doctors will approach the patient to gauge interest.

3. Why do some patients choose not to participate in clinical trials?

Some patients don’t like the idea of uncertainty, even if it gives them the option of new and experimental medicine. All of our standard treatments were once first tested as part of a clinical trial. Other reasons patients choose not to participate include the possibility of additional side effects and an aversion to intervention — sometimes it’s the extra blood draws, the extra testing or additional trips to the hospital. Some patients want minimal treatment while others want everything possible. It really is a matter of personal preference.

4. Can you tell us about a current clinical trial?

The “Match Trial” is a really large, ongoing study. It accepts patients with all different types of cancer. Acceptance is based on the cancer cell mutations rather than the area of the body that is affected. The Match Trial uses different drugs that rotate in and out of that study.

There is also a “Survivorship” study headed by Dr. Krishna Gunturu, an oncologist and Director of the Survivorship Clinic at Lahey Hospital & Medical Center that studies the positive effects diet and exercise have on a cancer patient’s lifestyle and their symptoms.

5. What if patients want to participate in a study but don’t want the hassle of going to a large academic hospital?

“For those who don’t want to be at a large academic center, we offer clinical trials at all of our Lahey Cancer Institute sites,” said Julie Roache, a Senior Clinical Research Associate at Lahey Hospital & Medical Center. “You don’t have to be at a big downtown hospital to participate in many studies.”

For more information on clinical research and studies being offered throughout Lahey Health, visit our website.

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*The content on this website is for informational purposes only and is not medical advice. Please consult a physician regarding your specific medical condition, diagnosis and/or treatment.

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