By Leon Hwang, MD
Over the past few years, I’ve seen an explosion in the number of clinical trials—a research study in which volunteers help scientists evaluate promising new ways to prevent, detect, treat or manage a medical condition—available to patients. According to the National Institutes of Health (NIH), there’s been a 60 percent increase in clinical trials concerning oncology alone over the past decade. That’s largely because new technologies, especially increasingly sophisticated genetic testing and the use of big data in medicine, have enabled us to make great strides in precision medicine. Based on an individual patient’s genetic makeup, we are able to better determine which patients are more likely to benefit from particular treatments.
A big potential benefit for patients is access to cutting-edge therapies. Some of my cancer patients enroll in clinical trials because the standard treatment for their condition isn’t working, or because there is no treatment currently available. Others hope for an improved prognosis—they may even be among the first to benefit from a successful new therapy.
One clinical trial we conducted at the Mid-Atlantic Permanente Medical Group (MAPMG) helped us improve treatment for women with breast cancer. A few years ago, we studied the impact of a drug used to treat osteoporosis on the recurrence of breast cancer in post-menopausal women. The trial was a success, and now we routinely use this medication for post-menopausal patients with high-risk estrogen-receptor-positive breast cancer, since taking it has been shown to reduce the risk of osteoporosis and the risk that their cancer will recur.
Of course, it’s important to understand that there can be unanticipated side effects during clinical trials, and not every experimental treatment turns out to be effective. Also, studies are usually randomized. That means you won’t know until the study is complete whether you were in the group that received the new treatment (along with the standard therapy), or in the control group that received only standard therapy.
Also, all clinical trials have eligibility criteria, which can include everything from your overall health status and past medical history to the type and stage of your disease and your treatment history. You can ask your doctor about promising trials, or search databases at the NIH. You can also check with specific organizations relevant to your diagnosis, such as the National Cancer Institute. Clinical trials are usually run by a doctor with a team of healthcare providers in a medical setting. You might ask your doctor to coordinate with the doctor running the trial to be sure it won’t interfere with your treatment.
Here are a few questions to ask when considering a clinical trial:
- What treatment is being studied and why do the researchers believe it will work?
- What will happen during the trial?
- How long will the trial last and what is expected of me?
- Will there be any pain or discomfort?
- What are the possible benefits and risks?
- What type of healthcare will I receive from the medical team?
- Will the treatment or the healthcare cost me anything?
- If the treatment works for me, will I be able to continue it when the trial is over?
A 2017 Zogby poll found that only 18 percent of Americans have participated in a clinical trial, mostly because they hadn’t heard of relevant trials from their healthcare providers. According to that same poll, a growing number of Americans believe it’s important to participate in clinical trials, and belive that it is as much of a civic responsibility as donating an organ or giving blood. Therefore, there is a need for better education about clinical trials, as well as increased participation from volunteers from minority groups as they are underrepresented in medical data.
To read more about participating in a clinical trial, visit NIH’s website or the FDA’s website. Individuals can contact their Congressional representatives to ask for additional funding for clinical research and trials.
Leon Hwang, MD, is a board certified oncologist with Mid-Atlantic Permanente Medical Group. He sees patients at the Kaiser Permanente Gaithersburg Medical Center.