How Re-educating PIs Can Improve Clinical Trial Diversity
By Dan Schell, Chief Editor, Clinical Leader
Usually, discussions around ways to improve diversity in clinical trials focus on what you would expect — changing traditional protocol-design processes, finding and tapping into larger pools of diverse patients, educating patients on the value of clinical trials — that type of stuff. You know what you don’t hear people talking about as a solution?
We need to re-educate and better educate physicians.
Right off the bat, that assertion is going to rub some people the wrong way — and be confusing. What are we re-educating/educating them about exactly? And how is any of this “new learning” going to affect the diversity problem in clinical trials?
This concept came up in a recent interview I did (see part 1 here) with Denise Bronner, Ph.D., director of diversity, equity, and inclusion in clinical trials at Johnson & Johnson Innovative Medicine (JJIM). In it, Bronner talks about how some of the legacy data regarding disease states is out-of-date or biased. Considering that data can be found in the textbooks physicians have been trained on, they could misdiagnose a patient simply because they have been trained that certain diseases only affect certain races or ethnicities. Further, having that predisposition may cause them to not even suggest clinical research for a patient.
“A great example is psoriasis,” Bronner explains. “A study from 2020 looked at some of the textbooks that are out there for teaching our medical students about different types of dermatological diseases. Only 4% to 18% of those books had images of skin of color. That's a very low amount when you think about the number of people in the world who represent or self-identify as someone who's not white. So, if we are not training our medical professionals the right way early on when they’re first learning about these diseases, they get out into the real world and that idea continues to stay in the system.” This same shortcoming is also a common criticism of using some type of AI like ChatGPT to self-diagnose a problem; it’s only pulling data from a finite group of information that could be biased.
Changing The Mindset Of PIs
To help alleviate this diversity-related problem, JJIM conducts scenario-based training with its PIs to help challenge existing diversity-related paradigms. Part of that training could include having the physician review a patient profile and answer questions such as, “What would you say to this patient? Would you say this person has this disease? How would you engage with them?” Often this training is conducted at investigator meetings, Bronner says. “We’ve gotten some really nice feedback from physicians who have said, ‘I never even thought of that,’ or ‘Oh yeah, I've had this happen to me before.’ It’s a safe environment where they can share this kind of candid feedback with their peers.” She adds that this type of training also clearly defines what JJIM expects from its PIs, so they know what they are signing up for when agreeing to be part of a study. Instead of traditional methods that focus only on empowering patients to be more educated and willing to speak up about their condition and interest to participate in clinical research, this strategy makes the physicians part of the solution, too.
Training PIs
Earlier this year, JJIM worked with the Skin of Color Society (SOCS) on training research-naive or research-limited SOCS members who wanted to enter clinical research. (SOCS educates HCPs and the public on dermatologic health issues related to skin of color.) During the first half of the program, participants learned how to set up their clinical research site, including topics such as GCP (good clinical practice) and GLP (good lab practices). In the second half of the program, they paired up with a seasoned clinical researcher who educated them on topics such as the type of staff to hire, the types of office resources they would need, and the ways in which they could streamline their operation to be more efficient with their time. “They get the didactic piece, but then they get that mentoring piece, too, which really helps when they get their first study,” says Bronner.
Additionally, JJIM, along with AstraZeneca and Merck, collaborated in 2021 on the National Medical Fellowships Diversity in Clinical Trials Research program (NMF Dctr), which is intended to increase the number of clinicians underrepresented in medicine who serve as PIs. The premise is that patients will feel more comfortable participating in trials if the PI is similar to them in race or ethnicity. Like the SOCS program, the NMF Dctr includes didactic and mentoring components.
Redefining “Diversity”
This concept of reeducation doesn’t stop at PIs, Bronner explains. JJIM’s global advisory boards have produced some valuable data points related to trial diversity, specifically, addressing the issue from a global perspective. “It’s been very eye-opening to hear how our European colleagues view diversity,” she says. “In the U.S., we are very focused on race. But in other parts of the world, they think beyond that; they take into consideration factors such as socioeconomics or where a person migrated from. They're looking at it more from an ethnicity point of view.”
A good example of the vagueness and confusion that surround the diversity topic is the use of the word “non-white.” According to the 2022 U.S. Census Bureau, approximately 41% of the population identifies as non-white, which could encompass Hispanics, blacks, Asians, native Americans, and people of Middle Eastern descent. Each of those subgroups could have different needs, and thus, require trial protocols that consider those needs. It’s that type of granular data analysis coupled with a reeducation of the stakeholders involved in trial design/recruitment that comprise the revamp Bronner insists is necessary if we are ever going to really improve diversity in clinical trials.