Improving patient access to clinical trials has long been a vexing issue for clinicians and patient advocates. Although trials are the backbone of cancer research, participation rates have remained unchanged in recent decades. As a result, more attention is being paid to the lack of diversity in clinical trial populations.
The National Coalition for Cancer Survivorship (NCCS) held its 2019 Cancer Policy Roundtable in Washington, D.C. late last year. It featured a cross-disciplinary panel comprised of patient advocates, a cancer survivor, researchers in health services and disparities, and a physician, all of whom addressed disparities in access to clinical trials and strategies for improvement.
Joseph Unger, PhD, MS, a biostatistician and health services researcher at Fred Hutchinson Cancer Research Center, introduced the current clinical trial landscape. Dr. Unger said that healthcare professionals typically hold the general belief that 2 to 3 percent of patients with cancer participate in clinical trials. But his research indicates that, in fact, 8.1 percent of patients with cancer take part in trials.
Dr. Unger’s study aimed to define and quantify the factors that create barriers to clinical trial participation. He said these barriers can include transportation difficulties, comorbid conditions, fear, and distrust of the medical establishment. He suggested that researchers, clinicians, and advocates start by addressing these barriers if they want to substantially increase trial participation rates among minority groups.
Patients at the roundtable shared their own challenges when looking for, applying to, or participating in clinical trials. Sharon Rivera-Sanchez—a clinical trial participant and founder of Saving Pennies 4 a Cure—shared her story about participating in clinical trials after she was diagnosed with triple-negative breast cancer. “I participated in two clinical trials; both I found on my own,” said Rivera-Sanchez. When asked how she found her first clinical trial, she responded, “Good Morning America,” eliciting surprise from the group. Rivera-Sanchez explained that the television show’s anchor just happened to be interviewing a physician who was promoting a new trial for triple-negative breast cancer patients.
Rivera-Sanchez left her first clinical trial because traveling to Los Angeles from her home in Richmond, Virginia, was too much of a burden. Afterward, she found a trial in Pennsylvania that, although closer to her, still required an eight-hour round-trip drive. Rivera-Sanchez’s description of her experience with clinical trials and the passion for patient advocacy they engendered in her set the mood for the remainder of the roundtable discussion.
Reaching Out
Rather than focusing on smaller, provider-based improvements (e.g., having one-on-one discussions with patients about clinical trials), the roundtable panelists discussed how larger institutions can address trial participation disparities.
Drawing on her own experience, Rivera-Sanchez said that many patients who are interested in clinical trials search online before speaking to their doctors. After her own diagnosis, Rivera-Sanchez said she turned to social media and the internet for information, even before her first consultation with her oncologist. She suggested that reaching patients via these channels can be more effective than traditional phone calls and mailings.
Panelists agreed that the circumstances of lower-income patients and language barriers can create significant obstacles to trial participation. The legacy of historical abuses in the medical research community—of which the Tuskegee syphilis experiment is the most-cited example—contribute to general distrust of the medical establishment by racial minorities. Glenn Ellis Sr., medical ethicist and president of Strategies for Well-Being, added that the way research is most often conducted can also be problematic. “There’s something structurally wrong with how we are doing research,” said Ellis, explaining that the structure and preconditions of trials often limit or eliminate participation by minority groups.
The panelists agreed that “regulation from the top down” can be unhelpful when trying to broaden clinical trial access. Tighter regulations on clinical trial design can add additional barriers to patient recruitment, such as longer washout periods or treatment delays. Dana L. Dornsife, a panelist and chairman of Lazarex Cancer Foundation, suggested leveraging industry competition by motivating companies to promote diverse enrollment and creating stronger requirements for diversity reporting.
The roundtable closed with panelists warning against the assumption that those underrepresented in clinical trials experience disparities mainly due to poverty and/or a lack of education. This creates a false narrative, they agreed. Designers of clinical trials must be careful to take into account the many ways in which some groups are excluded from trials if they truly want to diversify the populations in those trials.
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