In clinical research, everyone recognizes the need to incorporate underrepresented groups. Diversity and inclusion are not controversial concepts. However, translating these objectives into tangible actions is often challenging.
Achieving wider representation in clinical research will require that sponsors and other stakeholders invest as much energy in finding sites and participants from underrepresented populations as they do in other aspects of study planning. “If diversity and representation are going to be part of the overall end goal, then they need be taken into account with the same level of reverence and care as endpoints are,” says Seth Halvorson, General Manager, Site Solutions, WCG.
Study Level: Start at the Beginning
“You wouldn’t identify endpoints at the last minute, so don’t start looking for underrepresented populations at the last minute,” he argues. “The time to focus on your underrepresented population is before the study is enrolling. It needs to be part of planning through protocol development, timelines, site selection, and training.”
To find willing participants, it is important to consider the impact and challenges individuals face when enrolling in a clinical trial. Factors such as taking time off from work, travel arrangements, and securing childcare can significantly influence the readiness and capacity to participate. Study planning must identify these barriers and find solutions to unburden the participants, so that more are people who are willing can take part.
Sometimes, it can be as simple as getting participants to the site and making sure the visit runs on schedule. “That’s table stakes. That’s bare minimum,” Halvorson explains. “You’re asking somebody to go through a 10-week, 5-month, 18-month trial. You’re asking somebody to make this part of their life.”
Sites need to accommodate the participant, and sponsors need to empower them to do so. “The participants are the ones who raised their hand and said, ‘I want to participate in this study.’ We owe them a debt. If you want somebody to show up to test a therapeutic you’ve developed, it’s on you to make sure they can get there.”
New Sites Bring New Participants
Enrolling someone in a trial represents a commitment. “You must build trust. You must have a very core level of fundamental trust there, and sponsors and sites can’t take that for granted.”
One of the key challenges in achieving trust from diverse populations is that clinical trials tend to be conducted at the same locations repeatedly. Only about 3% of healthcare professionals participate in clinical trials, according to the US FDA, and new investigator participation continues to drop.
These locations are often not conveniently accessible for underrepresented populations.
Rather than confining efforts to individual studies, sponsors should focus on every study. “It has to be an intentional effort, and whatever the short-term needs are, these efforts must focus on the long term, not one particular study, but all studies that a sponsor might start,” Halvorson says.
To change this dynamic, sponsors must actively seek out new healthcare organizations and convert healthcare professionals into principal investigators (PIs), he says. “You need to take a healthcare provider and teach them what it means to conduct a clinical trial because it’s not the same process as providing care.”
New sites need to be engaged and current sites need to be trained and ready to engage underrepresented communities. Many organizations, including WCG, will take a healthcare professional and convert them into a PI. “It can be done. We need to do that, and we need to do that early—and not just for the sake of a single study.”
Halvorson acknowledges that sponsors often budget based on individual studies, leading to site activities being primarily tied to a specific study plan. “I get that. I understand the business sense of it,” he says. Nevertheless, sponsors need to start thinking longer term. That includes establishing new healthcare organizations as study sites and reaching out to healthcare professionals who have not previously engaged in clinical trials, with the goal of converting them into PI.
Keep Your Eye on the Goal
“If you’re standing up a healthcare organization as a study site because you have a need today, nurture it, but don’t demand immediate results to determine success,” he says. “If they don’t convert overnight, don’t look at that as a failure. Look at that as a starting point.”
The commitment to diversity and inclusion is pivotal in shaping a more equitable and effective clinical research landscape. Stakeholders to keep their eye on this collective goal, not just for a single study, but for the sustainability of their programs and the for the progress of the industry. This is a long-term journey, one that requires continuous effort, expansion, and an unwavering commitment to building a more inclusive future for clinical research.
“You’re planting seeds for the future. Don’t stop. Don’t limit it. Keep going.”
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