Trials & Tribulations: Pursuing a Clinical Trial Requires Determination and Education

Patients often find clinical trial restrictions make it difficult to participate.

After receiving a cancer diagnosis, some patients want to consider every option before deciding on treatment. Rather than waiting to enroll in a clinical trial as a last resort, they may be willing to explore the possibility upfront, seeking trials that include standard treatment in addition to the experimental approach. But identifying and ultimately participating in a study can be a challenge. Beyond learning the potential risks and benefits, patients should also understand the barriers around becoming involved.

Patients may be reluctant to participate in trials for a variety of reasons—they feel they don’t know enough, they might not meet strict eligibility requirements or they worry about how to cover the costs. Yet, as strange as it may seem, physicians are often a roadblock between patients and  trials. According to a 2010 report by the Institute of Medicine, primary care doctors might not mention cancer trials as a possibility because, as generalists, they often are unfamiliar with them—understandable, considering the National Institutes of Health track more than 122,000 clinical trials in 179 countries.

Oncologists might not mention them either—or may even discourage participation—if they object to less traditional treatments or worry about the additional time, cost and paperwork burdens they would bear on behalf of patients who enroll, a legitimate concern in this age of financially squeezed healthcare. A survey published in 2011 in the Journal of Oncology Practice found that 44 percent of 213 trial-eligible cancer patients did not recall discussing trials with their doctor.

If a patient’s oncologist doesn’t mention trials or balks at the subject, the patient should get a second opinion, says Richard Schilsky, MD, section chief of hematology/oncology at The University of Chicago Medicine, noting that an oncologist once advised one of his own family members not to become a “guinea pig.”

“Second opinions are worthwhile. Patients deserve to hear different points of view and have as much information as possible,” Schilsky says. “We know that patients have strong emotional attachments to their physicians; sometimes it’s a doctor they’ve been with for a long time. But at the end of the day, patients must do what hopefully will be best for them.”

Even if the patient’s oncologist is cooperative, finding an appropriate trial—much less one within a reasonable geographic distance—can be daunting, given every patient’s unique medical history, disease variables, demographic characteristics, eligibility criteria and the vast array of trials. David Spigel, MD, a clinical oncologist and director for the Lung Cancer Research Program at the Sarah Cannon Research Institute in Nashville, Tenn., encourages his patients to explore clinical trials databases on their own first. Later, during his free time, he digs through and narrows their findings to one or more studies he believes are most applicable—in effect, working as a translator, navigator and advocate for the patient.

“It helps me find a way to help,” Spigel says. “That makes things easier for everybody.”

[Read "Recruiting for Clinical Trials Takes Center Stage"]

Talk about this article with other patients, caregivers, and advocates in the General Discussions CURE discussion group.
CURE wants to hear from you! We are inviting you to Share Your Story with the readers of CURE. Submit your personal experience with cancer by visiting Share Your Story
Not yet receiving CURE in your mailbox? Sign up to receive CURE Magazine by visiting
//For side ad protocol