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In the Effort to Diversify Clinical Trials, Trust, Access, and Education Play Crucial Roles

Kelly Davio
While funders and researchers have long held that clinical trials should enroll more diverse patients to better reflect the populations in which approved drugs will eventually be used, patient populations enrolled in clinical trials remain largely homogenous.
In his practice, Hossein Borghaei, DO, chief of thoracic oncology at the Fox Chase Cancer Center in Philadelphia, Pennsylvania, also sees patient burden in terms of additional travel (some of his patients must take 2 to 3 different transportation modalities to reach the Center, he noted) and more intensive monitoring as a hinderance to trial participation.

Some patients, he finds—particularly younger patients with greater internet savvy—are beginning ask about participating in trials, particularly for immunotherapies for lung cancer, but he also finds that many patients lack familiarity with the nature of clinical trials and may have misconceptions that lead to concerns that can be resolved through education. Some may fear, for example, that they will be responsible for additional medical bills, which is not typically the case. Others, he says, fear that a clinical trial is only viable for a patient who has run out of other treatment options, which is also not the case. Finally, he notes that some patients are hesitant to even discuss a clinical trial because they fear that, if they decline to participate in a study, their oncologist will no longer treat them—a misconception that he says is crucial to clear up.

To help educate his patients, Borghaei typically addresses the potential of enrolling in a trial with a patient and their family members over the period of several visits. Patients considering a phase 1, first-in-human trial, he says, typically need greater discussion about their decision than do patients considering phase 3 studies, but he asks his patients to take home consent forms and read them over for several days before meeting again to discuss further questions.

This process, he says, can be a lengthy one, but it is crucial to educate patients about the fact that “without trials, we won’t make progress” in treating diseases.

Borghaei sees a need for a better educational methodology—one that is broader than individual efforts at cancer centers across the country—to raise awareness among patients so that they are more open to the possibility of participating in research.

That’s an objective that’s shared by David Charles, MD, chair of the Alliance for Patient Access and Coalition for Clinical Trials Awareness. Charles’ organization is working on a national campaign to raise patient awareness about the benefits of clinical trials.  

Public health awareness initiatives, says Charles, have been effective in generating more participation in organ donation, and given the similarity between organ donation programs and clinical trial participation—namely, the opportunity to benefit society, even if the individual does not reap benefits—Charles and the Coalition believe that a similar undertaking can change the public perception of clinical trials so that a broader range of patients view them as a feasible option.

Charles points to the success of educational campaigns in specific disease states—including the success of the Michael J. Fox Foundation for Parkinson’s Fox Trial Finder in enrolling patients in Parkinson disease trials—as evidence that education can change attitudes about research participation.

“What’s working in individual disease states really should be elevated to the public in general,” said Charles. “Our goal would be to elevate the level of understanding of all Americans…about what [clinical trials are] and how they benefit society such that, in the future, if a person had an illness or condition…that it would be more likely that they would at least think of or ask their physician” if there are clinical trials available to them.  

Knepper TC, McLeod HL. When will clinical trials finally reflect diversity? Nature. 2018;557(7704):157-159. doi: 10.1038/d41586-018-05049-5.

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