Clinical trials are a critical part of the research process. In fact, most providers would agree that today’s most effective treatments are based on trials that were conducted in the past. However, there is a lot for patients to consider when entering into trial treatment. Shannon Benson, who works with a Research Association that teams up with UnityPoint Health, helps us understand cancer clinical trials and what both patients and families need to know.
Clinical Trials Explained
Clinical trials are research studies that people volunteer to participate in, to test new drugs or procedures. Typically, patients get involved in a clinical trial by a physician referral. Some researchers work with cancer centers to screen all newly-diagnosed cancer patients to help identify a patient who may be eligible to participate. The center will notify the patient’s provider, and if the provider feels the clinical trial is a good option for the patient, the provider will make a referral, and work begins to develop the formal paperwork, which includes informed consent, required testing information and eligibility.
“In the past, clinical trials were often considered a last-ditch effort for patients,” Benson says. “This is no longer the case. We now have clinical trials that are for early diagnosed cancer patients.”
How to Find a Cancer Clinical Trial
Patients can join a clinical trial after a new cancer diagnosis or after their current treatment course fails.
“One of our most exciting treatment trials we are currently participating in is for patients who have exhausted the standard of care treatments for their disease or for a disease that no standard of care exists,” Benson says.
Benson continues to say there aren’t usually more trials surrounding one type of cancer or another. However, she adds that right now, there does seem to be a significant number of trials surrounding breast and lung cancers.
While your provider can suggest trials for cancer patients, patients can also look into the options themselves. Benson suggests cancer.gov/clinicaltrials, clinicaltrials.gov and iora.org. Benson says it’s not unusual for cancer clinical trials to run for several years.
“Even after a clinical trial closes to accrual of new patients, we continue to follow patients and submit data on them, sometimes for up to 20 years,” Benson says.
6 Questions to Ask
Before beginning a trial, it’s normal to have a lot of questions. While there are no good or bad questions, here are six that will get patients started down the path to discovery.
- Why do researchers believe that the treatment being studied may be better than the one being used now?
- How will the doctor know if the treatment is working?
- Who can I speak with about questions I have during and after the trial?
- How do the possible risks and benefits of this trial compare to those of the standard treatment?
- What happens if I decide to leave the trial?
- How does the treatment I would receive in this trial compare with other treatment choices?
Providers will also take it upon themselves to discuss certain trial topics with their patients. Those include the purpose, risks, benefits and side effects. Providers also remind patients that they can change their minds about being in the study, if they change their minds later. Finally, providers and researchers remind the volunteers that patients’ regular medical care will not be affected, if they decide not to participate in the study and their provider’s attitude toward them will not change.
Does Insurance Cover Cancer Clinical Trials?
Benson says many states require insurance companies to cover the costs of routine care for people taking part in a clinical trial. In other states, voluntary agreements between the states and insurance companies include such a provision.
“However, coverage varies by state, by health insurance plan and by the type of clinical trial. Typically, if anything is non-standard of care, it is provided free of charge by the study,” Benson says.
Clinical Trial Treatments and Placebo Use
Clinical studies use drugs, medical devices, vaccines, blood products or gene therapy in trials. However, before they are used in patients, they go through a testing process by the U.S. Food and Drug Administration (FDA). That process includes testing in laboratory animals, which helps determine the amount of each product that is safe to use. The treatments that show the most promise are moved into the clinical trial phase.
“As with any drug, there is the potential for side effects. In clinical trials, researchers and providers carefully and methodically test drugs and follow patients very closely. All patients who go on a clinical trial sign an informed consent that reviews possible side effects. The FDA typically requires proof of safety and effectiveness of a new anti-cancer drug in a large clinical trial before it can be used broadly in patient care,” Benson says.
Some cancer clinical trials use placeboes. However, Benson says patients who receive the placebo still get a normal course of treatment. Usually one group, the control group, receives the standard of care treatment. That’s the treatment that is normally accepted by providers as a proper and appropriate treatment for the cancer. The other group, known as the investigational group, usually receives the standard of care treatment, plus a trial drug. Some cancer patients fear they would only receive a placebo and no other treatment, but Benson says that is a rare scenario.
If you have any questions about cancer clinical trials, contact a UnityPoint Health oncologist or primary care provider.