In the effort to cure cancer, you might say that clinical trials are a win-win.
Patients who participate in trials win in a wide variety of ways, benefiting from advancements discovered during previous trials as well as their own participation in successful studies. Doctors win by having more treatment options to offer their patients. Researchers conducting the trials win because clinical trials provide the opportunities they need to determine what new diagnostics, drugs and other treatments are most effective, and which ones don’t work.
The opportunity to help doctors, researchers, and patients is why clinicians at Winship Cancer Institute of Emory University work to make sure every patient has the option to participate in a clinical trial that is right for them.
A clinical trial is a research study involving patient volunteers that is used to test new therapies to find better ways to diagnose, prevent or treat many diseases, including cancer. They help doctors and researchers tell if a new treatment works and is safe.
We discussed the clinical trials program at Winship Cancer Institute of Emory University with Mehmet Asim Bilen, MD, director of Winship’s genitourinary medical oncology program, who is actively involved as a researcher and doctor in clinical trials for genitourinary cancers such as cancer of the prostate and bladder.
Five Ways Patients Win
Patients are eligible to participate in clinical trials according to the type and stage of cancer they have, as well as their medical history and health status. Typically, studies define other characteristics and requirements for eligibility that ensure the treatment is safe and the results are accurate and meaningful. The eligibility criteria differ from study to study. Participation in a clinical trial is always voluntary, and a patient may withdraw at any time.
Bilen lists five ways patients benefit from participating in clinical trials:
- They may get a promising drug or new cancer treatment before it is available to everyone.
- They have more treatment options, which is especially valuable for those with cancers that haven’t responded well to current therapies.
- Extra care providers for the study closely check and monitor them.
- The clinical trial may cover the medication costs.
- They contribute to the advancement of cancer treatment for future patients.
Clinical trials also have potential risks, so patients should discuss the risks and benefits with their doctors.
How Researchers and Doctors Win, Too
“The only way – five or 10 years from today – doctors have better tools in our toolbox is through clinical trials,” says Bilen. Doctors and scientists like Bilen ask questions and test their answers in clinical trials to determine whether a new drug becomes a standard treatment that can benefit many more patients down the road.
Bilen says the number-one benefit clinical trials offer researchers is that they show whether a particular therapy is beneficial and is working. “This helps us understand if someone is responding to a therapy or not responding,” he says, “why that happens, how we can overcome obstacles, how we can learn from this to move the field forward and how we can develop biomarkers to tell us what’s happening.”
Clinical Trials Don’t Replace Standard Treatment—and Sometimes May Be the Best Hope
It’s important to emphasize that a clinical trial doesn’t replace standard treatment. “The patient should receive what is optimum plus what is involved in the trial,” says Bilen. They continue to receive the best standard of care, plus an investigational therapy. Sometimes, though, that patient already has gone through first-, second-, or even third-line treatment, with no good option left on the table.
“If this is the case,” says Bilen, “a clinical trial may try a novel pathway or novel drug. That is also a very important option for our patient because if there’s no good standard of care option left, bringing another option to the table is always very important for us in the field to move things forward—and at the same time, for our patient to get what is potentially promising for them.”
How Winship Selects Which Clinical Trials to Conduct
It’s easy for people with rare cancers who have exhausted their available treatment options to lose hope. But studies can encourage patients and edge the field, and patients’ prospects, forward a step at a time. For example, in a recent trial at Winship, 91% of participants with metastatic head and neck cancer – who have limited treatment options – experienced a clinical benefit, and in 54%, the cancer didn’t worsen in one year of trial treatment.
There are a number of layers in the process by which Winship decides which clinical trials to conduct. “First of all,” says Bilen, “we look at our patient population, and look at the gaps where we need a clinical trial.” He adds, “When someone comes to our clinic, we want to make sure we can offer something to them in terms of a clinical trial.”
To choose which clinical trials to offer, Bilen says individual physician-researchers review all clinical trials open in the field to make sure they select the best possible options for our patients. Then they meet in groups according to the cancer types in which they specialize to discuss those options. If the group decides to pursue one of them, scientific and regulatory committees will look at the trial to make sure it’s the best fit. After that, the trial can be activated and then patients enrolled in it.
Making Clinical Trials Even More Accessible at Winship at Emory Midtown
When Winship opens our new tower in Midtown Atlanta in spring 2023, the building will be organized in care communities according to cancer types. In addition to diagnostics and treatment, the specialists and researchers conducting clinical trials will be located within the same areas—making it even easier for patients to participate in them.
This arrangement further benefits patients because, as Bilen puts it, “Cancer care is a team sport, and a clinical trial is also a team sport.” He explains, “To make clinical trials successful, we need to have a multidisciplinary team that works together and thinks the same way about what is the best care possible for each patient. The design of the tower is going to promote this approach and make it even better and easier. Ultimately, I think our patients are going to benefit from this.”
How Many People Participate in Winship’s Clinical Trials—and Why Are They Important?
At Winship, approximately 1,000 patients enroll every year in what are called interventional trials, a type of clinical trial that tests treatments such as medications, medical devices or procedures. There are also observational studies that don’t test treatments, but involve collecting samples or questionnaires. “As a field, as a community,” says Bilen, “bringing novel and promising options to our patients is the only way we are going to cure cancer.”
Winship offers more than 300 clinical trials for virtually every cancer type.
About Winship Cancer Institute of Emory University
Winship Cancer Institute at Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given only to the top 3% of cancer centers nationwide for conducting cancer research and providing training that is transforming cancer care, prevention, detection and survivorship. Winship discovers, develops, delivers and teaches some of the world’s most effective ways to prevent, detect, diagnose and treat each patient’s unique cancer. Cancer care at Winship includes specialists with deep expertise and experience in cancer; multidisciplinary evaluation, treatment planning and care coordination that caters to each patient’s individual needs; therapies supported by the latest advances in cancer research; and comprehensive support services.