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PracticalApproachestoClinicalTrialDiversity “Diversity in clinical trials ... this is such a hot topic, so relevant to our industry,” says Claire Riches,Citeline Vice President of Clinical Solutions. She adds that although it has been top of mind for thepast couple of years, clinical trial diversity is gaining momentum. In a recent Citeline webinar, “Navigating the Maze of Diversity in Clinical Trials,” Riches and panelistsdiscussed best practices in increasing diversity in clinical trials and meeting new US Food and DrugAdministration (FDA) requirements for clinical diversity plans. As the charts below indicate, clinicaltrial participation does not reflect population demographics. Lorena Kuri, Director, Clinical Trial Diversity & Inclusion at Bristol MyersSquibb, concurs with Riches. “I think that since clinical trial diversity becamea relevant topic to others that were not probably very involved in this, wehave seen an increase year over year. In our case, the past 12 months, we’vebeen able to look to other types of relevant underrepresented groups thatin the past were not really considered.” In addition to racial and ethnicallydiverse populations, this includes sexual and gender minorities as well aspeople with disabilities. “How diverse are your study teams?” she adds. “Do you have someone whois representing the populations” you’re trying to recruit? She says it is alsoimportant to understand the baseline or distribution of gender equity inprincipal investigators. PracticalApproachestoClinicalTrialDiversity GSK started its diversity push with a 17-year retrospective study of its USclinical trial diversity. Clare Gibson, Associate Director, Global Demographics& Diversity Analytics for GSK, notes that this year GSK is ramping up itsdiversity efforts. “We expect 50 percent of our Phase III trials to meet orexceed the goals for recruitment.” By conducting outreach and gatheringfeedback from various patient populations, GSK has been able to unlocksome huge recruitment potentials. Gibson adds that the way GSK collectsdemographic data within its electronic data capture (EDC) forms matcheshow it sets targets for enrollment. Pfizer is implementing a multipronged approach to improve clinicaltrial diversity, including trial emulation. In traditional trial emulation,investigators collect existing data and apply it to measure the effectivenessof a medicine, instead of conducting a full clinical trial. Pfizer is applyingthis methodology to recruitment, says Leo Russo, PhD, Vice President andHead of Global Medical Epidemiology. He says Pfizer was “looking to seewhat inclusion/exclusion criteria really hurt our ability to recruit diversely.Is it hurting the patient pool? Is it hurting just how diverse the patientpool is?“ Russo says a diversity and recruitment plan is part of the clinicaldevelopment plans at Pfizer. AbbVie’s Natalie Monegro agrees with the multipronged approach. “We’vealso been working really diligently on building partnerships with patients andproviders so that we can incorporate their feedback into the developmentprocess early on along with reviewing our eligibility criteria, making surethat we’re being as inclusive as possible,” says Monegro, Vice President andHead of Global Medical Epidemiology. Riches emphasizes that having a clear diversity plan is just the beginning.Sponsors must actively engage and recruit a diverse patient pool. Kuriis quick to add that what works for one specific group may not work foranother. “It’s about understanding the nuances and the cultural needs that,for example, Black patients have versus what a Hispanic or Latino patientmay have,” she says. “One size for recruitment doesn’t fit all,” Riches agrees. Fenwick Eckhardt, Citeline Head of Diversity Strategy, says that in order totruly understand different patient segments, sponsors must look at differentdata points. In terms of social determinants of health (SDoH), for example,one must look at income, transportation, and urbanicity. “What do thesegroups need from an engagement, an education perspective?” “I’d also add that as well as having a good handle on the epidemiologydata and published literature data,” says GSK’s Gibson, “we’ve also got areally close eye on the census-level data as well, really to understand thoseintersections between some of the demographics….” PracticalApproachestoClinicalTrialDiversity The vast diversity among underrepresented groups requires sponsors tothink outside the proverbial box. “I think that as an industry we are gettingto be a little bit less risk averse and exploring innovation,” Kuri says. “Inthe past, who would have thought that either Amazon or Walmart or yourown pharmacy would invite you to participate in a clinical trial? … We’rebecoming a little bit braver on that space….” AbbVie’s Monegro reminds that in addition to creating awareness of anddriving recruitment for trials, sponsors also must keep caregivers in the loop.Diversity efforts should also be geared towar