Experts Debate Methods to Overcome Clinical Trial Enrollment Barriers
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:
- 56 percent of patients don’t have access to local trials
- 17 percent of patients will be ineligible for a trial due to exclusion criteria
- 27 percent of cancer patients will have the option of even enrolling in 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:
- Modernizing “eligibility/inclusion/exclusion criteria to achieve the most relevant parameters that will ensure scientific integrity without unnecessarily excluding patients” and making sure that racial or demographic groups are not “preferentially excluded” from trials “unless specific rationale for exclusion exists.”
- Encouraging “broad-panel biomarker testing programs to help promote simultaneous pre-screening for multiple targeted therapy trials”
- Ensuring that research sites selected for multi-site trials have diverse patient populations that reflect the broader population with cancer
- Presenting cancer patients with specifically identified trial options as part of the physician-patient treatment decision discussion using evidence-based methods
- Providing cost transparency by providing full coverage analyses on all trials to clearly articulate responsibility for all anticipated trial costs
- Providing clinical trial navigation services for patients from medically underserved groups to connect with publicly available support resources and culturally sensitive education materials
You can find the Action Network’s report here.
You can learn more about the Massachusetts General Hospital’s Cancer Care Equity Program here.