Oncologists discuss ‘magic wand’ solutions to improve clinical trial diversity
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An FDA Oncology Center of Excellence program titled “Real Talk: Our Stories as Black Oncologists at the FDA” included discussion about how to increase diversity in clinical trials.
Luckson Mathieu, MD posed a question to his fellow panelists, all physicians who work at the regulatory agency.
“We don’t need to describe the problem any further. It’s been described in the literature too many times,” said Matthieu, a medical oncologist and senior reviewer at FDA’s Division of Oncology 2, which regulates investigational new drug applications and biologic licensing applications for thoracic/head and neck cancers, neuro-oncology, rare cancers and pediatric solid tumors.
“I’d like to throw this out to the panel,” Mathieu added. “If you got that proverbial magic wand that you could wave and tomorrow morning your wish would exist, what would you do to fix this issue of diversity in clinical trial enrollment?”
Prior research suggested only about 5% of eligible Americans participate in clinical trials.
A study that examined trial enrollment from 2017 to 2022 showed lower participation rates for Black (4.4%) and Latinx (4.2%) individuals compared with white individuals (7.2%).
“When we look at the clinical trial data that we have, if we lack information on how these products perform in some of these populations, we are missing important information about safety, dosing and efficacy in these patients,” said panelist Nicole Gormley, MD, division director for the FDA’s Division of Hematologic Malignancies 2 and associate director for oncology endpoint development at the Oncology Center of Excellence. “It is really critical that we have diversity in the sites that are enrolling clinical trials.”
Gormley, who has had several family members diagnosed with multiple myeloma, noted that more diversity among the clinicians and staff at clinical trial sites could improve diversity in trial enrollment.
One of her aunts died of multiple myeloma after undergoing only one cycle of treatment, and Gormley cited the potential impact of medical mistrust.
“I don’t know if there was bias there or a lack of understanding, as well, but she felt that they didn’t understand what she was going through and were not willing to address her side effects,” Gormley said. “She received one cycle of treatment and said, ‘I’m done.’ I wonder if perhaps she was at a place where there was more representation and more understanding of her experience, there might have been a different outcome.”
Patricia Oneal, MD, who serves as a medical officer in the FDA’s division in nonmalignant hematology, emphasized the need for pharmaceutical companies to reach outside their typical treatment centers and recruitment sites when enrolling patients.
“When you’re in a low-resource setting or center, you may have to negotiate with that pharmaceutical company possibly on hiring a clinical research nurse, or a clinical pharmacist, or a statistician,” Oneal said. “It’s not that the patients aren’t there, or that they’re not interested in participating in clinical trials. Pharmaceutical companies need to make the investment of targeting other sites that are not their typical treatment sites to recruit these patients.”
Although not every patient may be a suitable candidate for a trial, access to clinical trials has demonstrated clear value, according to panelist Oladimeji Akinboro, MD, MPH, acting associate director of FDA’s Office of Oncologic Diseases.
“Although there are caveats to the interpretation of it, we do have data showing us that patients who participate in clinical trials generally have better outcomes than those who do not,” Akinboro said. “I understand that some patients might have better comorbidity status or better performance status, but I don’t think anyone seriously doubts that having access to a clinical trial should be standard of care. Patients should have access.”
Panelist Ashley C. Woods, MD, a hematologist and clinical reviewer at the FDA’s Division of Hematologic Malignancies 1, emphasized the importance of making clinical trial participation realistic and feasible within the context of an individual’s daily schedule.
Woods previously practiced at Atlanta’s Grady Memorial Hospital. Approximately 80% of the safety net hospital’s patients were racial or ethnic minority individuals.
Woods said she would use her “magic wand” to make clinical trial participation more patient-friendly.
“When patients are diagnosed with cancer, they also still have their lives going on. They have to go to work and they have bills to pay,” Woods said. “For some of these clinical trials, they want patients to come in on multiple days to get multiple lab tests, which requires them to take time off. Not everyone is on a salary, and not everyone has a lot of PTO time that allows them to come in for 2 or 3 whole days.”
Woods noted participation in a cancer clinical trial does not necessarily eclipse other everyday priorities, such as caring for children or other family members. She acknowledged the FDA’s efforts to increase decentralized clinical trials, noting that this may allow for patients to participate at trial sites closer to home.
Regardless, Woods added, “clinical trials are not easy.”
“I have a cousin who is currently in a clinical trial, and she spends all day at clinic getting her [pharmacokinetic/pharmacodynamic] data,” Woods said. “She can’t go to work, and that is a paycheck or money that she’s not going to be able to earn for her kids. So, my ‘magic wand’ would make trials a little bit more patient-friendly, so we can enroll more minority patients.”
Panelist Jamie Brewer, MD, medical oncologist and clinical team lead in the FDA’s Division of Oncology 3 in the Office of Oncologic Diseases, challenged the medical profession to consider the needs of minority participants throughout the entire clinical trial trajectory.
“We need to change the culture of approaching patients,” she said. “Rather than predicting that they won’t be good candidates or predicting that they won’t be able to do it, we should maybe think about how we can make them a better trial participant [and] how we can make them more able to come to clinic.”
Although accruing these patients is a victory, it should not be considered the end of the story, Brewer added.
“The goal should be more than a name signed on a consent form,” Brewer said. “The goal should be getting the patient through the trial, getting the patient to feel better, and helping the patient live longer.”
Reference s :
- FDA Oncology Center of Excellence presents Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” (press release). Available at: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-oncology-center-excellence-presents-conversations-cancer-black-history-month-program-real-talk. Published Feb. 27, 2024. Accessed March 11, 2024.
- Pittell H, et al. JAMA Netw Open. 2023;doi: 10.1001/jamanetworkopen.2023.22515.
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Conversations on Cancer, Black History Month Program: Real Talk: Our Stories as Black Oncologists at the FDA
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