DE&I Initiatives May Need An Accessibility Component
By Deborah Borfitz
February 21, 2022 | Ensuring the Black voice in clinical research was the focus of a panel discussion on diversity, equity, and inclusion (DE&I) at last week’s Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. The conversation was led by two-time cancer survivor Kimberly Richardson, president of the Black Cancer Collaborative, who vividly recalls being scolded and silenced when she questioned why her slow-growing granulosa cell tumor needed to be aggressively treated with three-drug medicinal cocktail.
Ensuring that patients have an open and respectful relationship with their physician, and understand their disease and the research process, is motivational to panelist Monique Phillips, clinical trial recruitment strategy lead at Bristol-Myers Squibb (BMS) and director of community engagement for Women of Color in Pharma. “Their stories are not being heard,” she says.
A desire to improve representation and equity in cancer research drives the work of panelist Nikhil Wagle, M.D., assistant professor of medicine at Harvard Medical School and medical oncologist at Dana-Farber Cancer Institute. He directs the nonprofit Count Me In, giving cancer patients anywhere in the U.S. or Canada a platform to openly share their experiences, data, and voices with researchers. Too often, he says, he sees patients who didn’t get the right treatment.
Lived experiences helped carve the job path of panelist Karriem Watson, chief engagement officer for the All Of Us Research Program of the National Institutes of Health seeking to gather data from more than one million people to accelerate health research. “Community engagement does not always go hand in hand with recruitment,” he says, noting that it would be less problematic if researchers first built relationships with would-be participants.
When he was seven years old, Watson’s birth mother died of cancer, he shares. His new mom got lung cancer, although she never smoked, but molecular testing for her tumor type landed her on a treatment that extended her life by 18 months—which might not have happened had he not been a researcher.
Watson, also a cancer researcher at the University of Illinois for the past six years, says he ignored well-intentioned warnings that focusing on black men would be a career-hindering move. This was, after all, his social circle and many of them were simply unengaged.
Based on the false premise that minorities don’t participate in research due to mistrust, over 200 residents on the South Side of Chicago were live-polled a few years ago on their thinking about beliefs about clinical trials and precision medicine, says Richardson, who previously worked with the Oncology Center of Excellence of the U.S. Food and Drug Administration. Contrary to expectations, most everyone in the room was well informed on both, “so we got an education.” The real problem is that Blacks have historically not been invited to participate in clinical research.
Assumptions need to be challenged, says Phillips. At Memorial Sloan, 30% of Blacks say yes to a trial when asked. “We need change the conversation… solve for the right problem.”
Accessibility issues lie at the heart of recruitment difficulties, the panelists seem to agree, among them the absence of education about clinical trials delivered in a relevant format and context and by the right messenger. Added to that are the more direct roadblocks to participation related to the geography of a study and the financial implications of saying yes as well as not being asked to join in the first place.
Statistics shared at a separate session at SCOPE underscore the magnitude of the disparities problem in clinical trials, based on an analysis of aggregated deidentified participant data from Reify Health’s Study Team platform. Out of every 100 clinical trial candidates who are Black, only 23 will ultimately enroll versus 40 out of every 100 White candidates. From the pre-screening phase, 31 Black candidates will proceed to in-screening compared to 50% of white candidates.
The research was pulled from Reify’s new feature called StudyTeam Diversity Reporting, which sites and sponsors can use to understand whether they are effectively engaging patients from traditionally underrepresented minority communities.
Trustworthiness And Sensitivity
The problem with the mistrust narrative is that is “puts the onus on patients rather than the health system,” says Watson. Trustworthiness of health systems is what needs addressing, and that includes engaging more Federally Qualified Health Centers in clinical research.
Issues of access and equal treatment exist even without medical mistrust, adds Wagle, who is likewise in favor of the notion of trustworthiness. Without it, those championing DE&I in clinical research are only wasting time and effort. Would-be participants need to know they will be appropriately represented in research projects, he says.
It is likewise important to respect people by showing “due regard” to their customs and traditions, as evidenced by the choice of images used in recruitment brochures, Phillips says.
When it comes to discussing trial design and complexity, Watson says he prefers to talk about cultural sensitivity (versus competence) since it is what enables indigenous knowledge to be honored. He once served as study coordinator for a diabetes trial where 140/80 was the upper allowable limit on blood pressure readings, which effectively disqualified everyone in his family, he adds, highlighting the importance of cultural humility and population-specific medical knowledge.
Cultural sensitivity, knowledge, trust, and familiarity are a necessity, agrees Wagle. Research teams need to be diverse and inclusive but also work closely with patients and advocates who can help educate them. Patient feedback has changed both the approach and brochure of the Count Me In initiative over the past few years, he says. “Whatever we heard we implemented.”
Richardson interjects that she has personally grown “cartoon-averse” after years of viewing promotional materials endeavoring to boost trial diversity.
Separate from community- and trust-building work, diversity and cultural sensitivity need to be developed at the team and institution level and any problematic issues of equality addressed, says Wagle. Count Me In launched its Amplifying Black Voices Across Cancer website where people can tell their stories, without any call to action, because amplifying their experiences is “important in its own right.”
The direction being taken by BMS is highly reflective of the other organizations represented on the panel. This includes establishing relationships before they’re needed, writing protocols with more sensible inclusion/exclusion criteria, and having people at the table who understand cultural competence, says Phillips, since “you don’t know what don’t know.”
Equity And Access
To help make trials more accessible, leadership must “bake in health equity,” says Watson, noting that the concept of hard-to-reach scientists is a myth. A more diverse investigator pool might result from the admission of more Black men into schools of public health to feed into the research pipeline—provided implicit bias doesn’t traumatize them once they get there, he adds.
More emphasis belongs on the equity piece, says Watson, citing as an example the greater technical assistance community partners may need in completing grant applications than the typical academic partner. Accessibility should also be added to the DE&I mantra, to be sure persons of color can even get in the door.
One session attendee says the cultural respect piece is deliberate for her family in that they see only African American providers who look like them. But she lives in the Research Triangle area of North Carolina where residents can select from a bevy of diverse providers.
Among oncologists, Richardson points out, only 8% are persons of color. “We have a long way to go.”