Health Innovations

Understanding clinical trials

An important component of academic programs like the UC Cancer Center is conducting medical research. A clinical trial, also known as a research study, is a carefully planned test. Ultimately, clinical trials combine science, research and clinical care with the goal of helping patients live longer, healthier lives.

“We’re bringing therapies from the lab to the clinic that offer the hope that we’re going to be curing or allowing cancer patients to live with their disease long term,” explained John C. Byrd, MD, UC Health physician and the Gordon and Helen Taylor Professor of Medicine and chair of the Department of Internal Medicine at the University of Cincinnati College of Medicine, an internationally-known cancer researcher and physician, specializing in caring for patients with lymphocytic leukemia and acute myeloid leukemia.

A common fear of clinical trials is that participants are treated as guinea pigs. However, clinical trials are the final step in a long process that begins with research in a lab. Before any new treatments are used with patients in clinical trials, researchers work for many years to understand its effects on cancer cells.

There are numerous types of clinical trials, each with a different purpose:

• Treatment: Test new treatments, combinations of drugs or new approaches procedures like surgery or radiation therapy.
• Prevention: Look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, immunizations, vitamins, minerals or lifestyle changes.
• Diagnostic: Find better tests or procedures for diagnosing a particular disease or condition.
• Screening: Test the best way to detect certain diseases or health conditions.
• Quality of life: Explore ways to improve comfort and the quality of life for individuals with a chronic illness such as cancer.

Not only are patients who participate in UC Cancer Center clinical trials followed for an extended period of time, the process is closely regulated by the U.S. government and monitored by UC’s Review Board.

Importance of cancer clinical trials

The approval process for promising new cancer therapies can be years long. At such a critical time, patients do not have the option to delay treatment until a new therapy is available—especially patients who have exhausted standard treatment options. Clinical trials offer new possibilities for patients in all stages of disease, providing access to new treatments before they become widely available.

“There’s so much hope now with new therapies, and science and integrating it with clinical care is something that’s happening at the UC Cancer Center,” said Dr. Byrd.

Patients who participate in clinical trials aren’t just receiving exclusive access to novel treatments. These patients are playing an active role in their own healthcare and are helping others by contributing to medical research.

Beat AML: Nation’s first collaborative precision medicine clinical trial for blood cancer

One of the exciting clinical trials offered at the UC Cancer Center is the Beat AML Master Clinical Trial, the nation’s first precision medicine clinical trial for blood cancer, led by Dr. Byrd.

According to Dr. Byrd, acute myeloid leukemia (AML) is the most diagnosed and deadly adult leukemia—among adults over the age of 60, only about one in four AML patients survives five years after diagnosis.

“For the first time, this study moves treatment to an individual basis instead of treating newly diagnosed AML as a single entity,” said Dr. Byrd. “We are moving away from chemotherapy for patients where chemotherapy won’t cure the disease. Targeted therapy is more patient-friendly than what we have been using to treat patients.”

Because AML is not one disease, the BEAT AML study uses genetic testing on leukemia cells to determine what subset of AML the patients have. Once each patient’s cancer-driving genetic mutations are identified, they are matched to the most promising, targeted treatment.

Since enrollment began, results show a promising therapeutic benefit. As more is understood about the disease and more targeted therapies become available, disease outcomes will likely be improved by matching patients to the right therapy.

“Our hope is that genetics-based approaches will lead to curative therapies, not just short-term improvements,” Dr. Byrd added.

Offering hope for cancer patients

Clinical trials can be a source of hope for cancer patients. While people often consider clinical trials as a last option when other treatments have failed, that’s not always the case. UC Cancer Center researchers design clinical trials specifically with our patient population in mind and encourage clinical trials consideration for people who:

• Are newly diagnosed with cancer.
• Are in the Greater Cincinnati area.
• Have had a recurrence or progression of their cancer after receiving their first line of therapy.
• Have exhausted standard treatment options.

To learn more about clinical trials, call the UC cancer clinical trials office at 513-584-7698.