What You Need to Know about Clinical Trials

By James Donovan, MD

Research is a critical part of UC Health’s mission. We are dedicated to exploring innovative ways to treat and manage conditions from diabetes to epilepsy, angina to prostate cancer, and much, much more. As a physician, it is fascinating to be on the forefront of discovering new ways to help people manage a chronic condition. But while we physicians are involved in the trenches of clinical trials, our patients are not always aware of these studies and their potential benefits. Here’s a quick guide on what you need to know about clinical trials.

What is a clinical trial?

A clinical trial is a rigorously controlled test of a new drug, medical device or treatment approach on human subjects. Clinical trials are conducted before the drug or device is made available for general use to help determine its effectiveness and safety.

During the clinical trial, two (or sometimes more) groups are closely studied. Outcomes are compared to determine if the medicine, device or treatment approach is effective and safe. Clinical trials are conducted under the direction and supervision of the U.S. Food and Drug Administration.

There are three different types of clinical trials:

  • Randomized controlled trials are often used to test the effectiveness of medical intervention, like a new drug or treatment approach. Patients who meet the entry criteria are chosen at random to fit into one “arm” of the study or the other: those who receive the new drug or treatment and those who don’t. Researchers follow them closely to monitor and compare the effects of the drug or treatment under study.
  • Blinded clinical trials are those in which the physicians and healthcare providers managing the trial do not know which patients are receiving the test treatment or which patients are receiving a placebo.  Information is kept from the subjects, the researchers, or sometimes both, until the study is complete to prevent bias in recording the responses to treatment.
  • Safety trials help rule out any increased risks associated with the drug, treatment or device under investigation.

Why should I consider participating in a clinical trial?

Clinical trials often offer hope to patients dealing with a chronic condition that has not responded to traditional treatment.

Are any prostate cancer clinical trials taking place at UC Health?

UC Health is currently offering a clinical trial for a new treatment method for men diagnosed with prostate cancer, called high-intensity focused ultrasound (HIFU). It is funded by industry and overseen by the FDA.

HIFU focuses energy from an ultrasound to a precise area of the prostate, heating the tissue to a boiling point and killing the cancer cells without harming the surrounding area.  This clinical trial is restricted to men experiencing a recurrence of prostate cancer after undergoing external beam radiation therapy.

For more information about the HIFU clinical trial or to find out if you may qualify for participation, please call Barbara Burke at 513-558-4060.

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