Clinical Research Nurse Manager Judy Bosley, RN, BSN, CCRP, says a stigma still surrounds clinical trials.
"Sometimes, people are just a little leery of clinical trials. They're skeptical," Bosley says.
To shed some light on what really happens during a clinical trial, here are the top five frequently asked questions.
Who is qualified for a clinical trial?Bosley says a common misnomer about clinical trials is that they're a "last-ditch" effort for patients.
"We have clinical trials that span across all different phases of treatment, from patients who have early-stage cancers all the way to advanced stages," Bosley says.
She adds that GBMC HealthCare offers trials for many different types of cancers and stages, including but not limited to breast, lung, colorectal, gynecologic, head and neck, blood-related, skin, prostate, and pancreatic cancers. But with 50 to 60 trials going on at any given time, she encourages patients to explore the options for their specific situation.
Clinical trials may not be right for patients who are short on time or who have trouble fitting their current treatment into their schedules, according to Bosley.
"There's a little bit more of a time commitment (with participation in a clinical trial). There are certain visits they have to make and stringent timelines," Bosley says.
She says researchers try to minimize the time commitment as much as possible, but it's important to take an honest look at your schedule before committing to a clinical trial.
What are the risks involved?Bosley says patients often ask whether they're just a guinea pig in the clinical trial process. She responds with a resounding, "no." Bosley adds that potential trial participants are often concerned about receiving a placebo instead of proper care for their cancer. She emphasizes that would never happen. GBMC trials typically compare drugs or analyze combinations of therapies to find what works best. Others are aimed at determining optimal dosage or protocols. Regardless, every patient receives quality treatment.
"The only time there's a placebo added to a study is if it's in addition to what we know is the best care available," Bosley says.
There is always a risk of side effects when the trial involves a drug treatment, but each patient is monitored closely to help mitigate potential risks. Bosley says one of the biggest risks is that the patient may not benefit from the trial.
"Just like we can't guarantee they're going to benefit when we start any treatment, we can't guarantee that a patient is going to benefit from the clinical trial," Bosley says.
How much will it cost to participate in a clinical trial?Patients generally don't have to pay any extra out-of-pocket costs for treatments received as part of a trial. Usually, the trial sponsor pays for research-related costs and any special testing. Any standard care costs (routine tests, treatments, or procedures) would be covered by the patient, and any insurance the patient has. Bosley says federal law requires most health insurance plans to cover routine care costs in clinical trials. A health insurance provider cannot prohibit a patient from entering a clinical trial or limit a patient's benefits. Before joining a clinical trial, you will receive an informed consent document that spells out the payments you'll need to make.
How long will the trial take?The length of the study varies significantly based on the trial. Bosley explains it's not just the treatment time that goes into consideration for each trial. The short- and long-term follow-up are important as well.
"We can be following patients up to 10-20 years, but the follow-up is usually an annual check-in that coincides with a visit to the physician," she says.
For patients with late-stage cancers, the treatments can continue for a longer period of time, especially if they're effective.
"We usually don't end treatments on the study if it's working and the patient is benefitting," Bosley says. "The number of cycles can be unlimited."
How will I benefit from participating in a clinical trial?The short answer is that you'll get personalized care during your treatment, along with access to potentially cutting-edge therapies that could benefit your health. But it's the contribution to the greater good that Bosley thinks drives most patients to participate.
Current treatments are available because of those who participated in previous trials. The bottom line is that taking part in a clinical trial is a valuable contribution to cancer research.
"They're in this awful situation with this awful disease, but they're able to contribute and give back to somebody, whether it helps them or not," she says.