A recent FDA guidance clarifying that sponsors may reimburse travel or daycare costs for patients in clinical trials removed a barrier to patient enrollment, but significant barriers remain.
The more than 30 experts and patients gathered at a roundtable discussion hosted by the Lazarex Cancer Foundation and Critical Mass: The Young Adult Cancer Alliance in Washington last week were divided over the solutions.
They met just a few months after the FDA changed language in one of its guidances that had previously considered reimbursements a form of inducement to enrolling in a clinical trial. All present agreed that the change was a great first step toward improving enrollment in cancer trials.
One potential model to improve enrollment comes from Massachusetts General Hospital’s Cancer Care Equity Program, co-sponsored by Lazarex. Program organizers regularly fan out into minority communities and record public service announcements for urban radio stations, said Jonathan Jackson, principal investigator at Mass General.
Since launching the program just a few years ago, researchers have been able to double minority enrollment and increase overall enrollment by 29 percent by focusing on helping patients improve their “basic literacy skills” in areas such as health, research and even insurance policy, Jackson said.
“What we need to remember is that what we are doing, to the average American, is deeply weird,” Jackson said. “They don’t know what this work is.”
In a separate panel discussion, however, Kate Yglesias Houghton, Critical Mass’ president and CEO, said she wasn’t sure that knowledge was power. A survivor of leukemia, Houghton said that for young adults, raised in the post-Google era, education is less a problem than the steep economic and even social barriers to meaningful participation in clinical trials.
“You can’t get deferments on your student loans if you’re diagnosed with cancer,” Yglesias Houghton said, referring to one economic barrier.
As to social barriers, only five states have laws requiring care providers to warn their patients of the risk of infertility from cancer treatment and compounding a social anxiety with an economic anxiety in vitro fertilization isn’t usually covered by insurance plans.
In April, the American Cancer Society Cancer Action Network released results of a survey on barriers to enrollment in clinical trials:
The biggest barriers, Action Network Policy Principal Mark Fleury told the crowd, are patient awareness, but also patient fears, either of side effects or a loss of control of care, followed by practical concerns such as costs or logistics.
The Action Network’s report made 23 recommendations for improving enrollment in clinical trials, including:
You can find the Action Network’s report here.
You can learn more about the Massachusetts General Hospital’s Cancer Care Equity Program here.