Clinical trial experts from across the entire industry ecosystem took on the vexing problem of underrepresentation of minority populations in clinical trials at a September 15 summit sponsored by the Association of Clinical Research Professionals (ACRP) and The Avoca Group.
Evonne Lackey, CCRP, director of clinical research at the Swedish Cancer Institute, said the industry must do more in terms of funding and creativity when reaching out to non-English speaking populations. She cited some of the institute’s studies in which it was difficult getting funding to have consent forms translated from English into a potential patient’s native language. Further, translators don’t always understand research and can’t or won’t offer opinions on whether a patient understood the consent process.
“Listen very closely to patient concerns,” said Ana Santos Alejandro, director of corporate quality relationships for Syneos Health. She suggested coming up with different communications offerings for different audiences. For example, animations have been shown to be effective as part of the informed consent process in some cases. “Come to them with different options” to understand the trial, Alejandro said.
For outreach to underserved populations to be durable and effective, Sharon Hanlon, head of clinical trial engagement and enrollment for BMS, said it can’t be “transactional” in approach. “We need more clinical trial staff of color and community embedding,” she noted.
Andy Lee, senior vice president and head of global clinical trial operations at Merck, noted the industry has tried for years to fix the problem. “The intent is there,” he said, noting Merck has made promising inroads into minority communities with some of its HIV-related trials because “we have a genuine desire to engage [and increase] trust” in the clinical trial recruitment process among African-Americans and other underrepresented groups.
Patient advocate T.J. Sharpe called on industry to be more proactive in its efforts. “Just engage [with patient advocate groups] now—don’t wait until you need a patient,” said Sharpe, who serves as a patient advisor with Starfish Harbor.
Echoing Sharpe’s call, Steve Whitaker, president of PharmaPM Consulting, said effective minority outreach “has to be done in a collaborative way, across the entire [clinical trial] ecosystem.” Frankly, Whitaker said, the clinical trial industry must acknowledge it has a “reputation with evil intent” in the eyes of some Americans.
Calling the fear and distrust of clinical trials among many in minority communities “very alarming,” Jennifer Byrne, CEO of Javara Research, lauded the “important work being done by ACRP to be an educating force” raising awareness of the problem and helping industry come up with solutions to improve diversity in patient populations.
Lamenting the “diversity dilemma,” Grace Crawford, global head of clinical quality and compliance for AstraZeneca, said her organization has had some success leveraging employee network groups to go into communities and “break down barriers of mistrust.”
Author: Michael Causey