Diversity at the Start: Best Practices for Clinical Trial Planning

According to Claire Riches, Citeline Vice President of Clinical Solutions, it is important for companies in the clinical space to begin their clinical trial diversity efforts with a fit-for-purpose clinical protocol. “We need to start at that point, if not earlier, in terms of how we’re incorporating diversity, patient voice, etc., so we can really set those studies up for success in terms of bringing in the right patient populations,” Riches says.

In a recent Citeline webinar, “Navigating the Maze of Diversity in Clinical Trials,” Riches and panelists discussed best practices for incorporating diversity into clinical planning.

GSK has made it part of its diversity strategy to embed scientific questions for population-related responses in its study protocols.¹ Clare Gibson, Associate Director, Global Demographics & Diversity Analytics for GSK, says this is a top priority for the company.

“Internally within GSK as well, we’ve recently run a series of lectures in healthcare disparities where we’ve had external speakers come and speak to our clinical operations protocol planning staff around how can we make our protocols more patient focused and how can we make them adaptable to what is happening on the ground in our trial sites,” she says.

Also on the protocol planning side, Gibson adds, GSK is ensuring all its data sources are aligned and working consistently. “That means the way that we collect demographic data within our EDC (electronic data capture) forms matches the way that we are setting targets for enrollment and making sure that every study is consistently reporting that data in the same way,” she says. “So, there has been quite a lot of effort recently in harmonizing all our data sources and doing some standards checking.”

Leo Russo

Leo Russo, PhD, Vice President and Head of Global Medical Epidemiology for Pfizer, says the company has made a public commitment ² that all its trials will achieve participation in the US at census or disease epidemiology levels. His group then developed a framework to determine how to set these goals.

“We’ve been rapidly taking the next steps, really baking it into … clinical development plans, preparing for our SOPs [standard operating procedures] how are we going to respond to FDA diversity action plans,” Russo says. “And then specifically in epidemiology, we’ve been seeing how vertically we can facilitate it.”

In terms of protocol development, Russo says Pfizer is testing what works as far as criteria, design, and patient populations, and using a lot of data for that.

“Within our framework of what we’ve done, we try to not make exceptions,” he says. “But for instance, with different diseases, even if there isn’t an imbalance in demographics, is there a severity issue?

“For instance, one of the diseases that is in our framework is bladder cancer and African Americans. The disease population roughly looks like the census population. However, [African Americans] have much more severity. So, we are accounting for oversampling as well as access issues. It’s important to have a base or a floor of what the disease population looks like, then raise it from there with different considerations.”

In order to achieve its diversity goals, AbbVie is evolving its existing protocols, frameworks, policies, and ways of working to better serve the needs of the patients affected by the diseases it is studying. ³

Natalie Monegro

“We have an established methodology for how we benchmark our trials,” says Natalie Monegro, Vice President and Head of Global Medical Epidemiology for AbbVie. “We’re using the epi [epigenetics] data. We have close partnerships with HEOR [health economics and outcomes research] and global epi teams to be able to create those benchmarks. And we’re applying that across the board in all of our therapeutic areas.

“Obviously we want to have inclusive designs,” she adds. “We want to make sure their eligibility criteria are as broad as possible. … Anything that we do as part of protocol planning then gets included in our diversity plan. We capture everything from pretrial to on trial to post-trial in our diversity plan or in a subsequent update to our diversity plan in terms of the patient voice.”

Protocol simulation is often part of the process for integrating the patient voice at different phases in the decision-making process, she adds.

As part of its commitment to diversity in clinical trials, the Bristol Myers Squibb Foundation runs the Robert A. Winn Diversity in Clinical Trials Award program. This five-year program develops racially and ethnically diverse clinical investigators, as well as investigators committed to increasing diversity in clinical trials. It also exposes promising medical students from underrepresented backgrounds to clinical research career pathways. ⁴

Lorena Kuri

Lorena Kuri, Director, Clinical Trial Diversity & Inclusion for Bristol Myers Squibb (BMS), says BMS is looking into how its eligibility criteria may be inadvertently screening out certain patients. “Once we identify it, I think that the biggest challenge is once you have that information, how do you make the clinical study teams unlearn and relearn what they have been doing for years? And that can take time….

“So, how do you make them understand that, well, probably you need to think differently about uncontrolled diabetes in Black patients when you’re recruiting patients for multiple myeloma trials? Or serum creatinine. Just making those changes requires a lot of effort. … And of course the design should always continue incorporating the patient’s voice….”

GSK runs studies specifically to understand what some barriers to participation may be. “In the HIV space we have a study called EBONI with 100% enrollment within the Black cisgender and transgender female population to really understand the barriers to the usage of the PrEP [pre-exposure prophylaxis] treatment for this population,” Gibson says. “Understanding that uptake needs some improvement, but we haven’t yet got that understanding for the implementation strategies that we need. So, running protocols purely to understand those barriers as well.”

Russo says Pfizer is also delving into what diversity means for its global trials. “FDA has left that as a blank a little bit,” he says. “We want to make sure our CRFs [case report forms] are collecting the appropriate culture and country measures of diversity or underrepresentation. And how do we do that? We know … in the diversity plans … you’re going to have to account for patients outside the United States, but what does that mean? We’re trying to figure [that] out….”

Kuri says continuing to make progress on diversity in clinical trials can be a bit of a maze where once you get where you think you’re going, you need to go back and rebuild to some extent. “It’s a marathon,” she says.

Monegro says while “there is no silver bullet solution,” she believes the creation of new titles around diversity is a testament to the progress that’s being made in the industry.

“None of us can work in a silo,” she says. “I think that the increase in roles and titles really reflects that, and we’ll probably continue to have an evolution of titles and roles.”

Monegro observes the FDA’s diversity plan guidance is currently under executive order review.  “With that new guidance, I’m sure we’ll shed some new light on challenging aspects of creating diversity plans … and there will probably be more growth in this space after that,” she says.

See more trial diversity webinar insights from the patient engagement and recruitment perspective.

¹ GSK, Diversity in clinical trials. Available from: https://www.gsk.com/en-gb/innovation/trials/diversity-in-clinical-trials/ [Accessed April 30, 2024]

² Pfizer, Diversity and inclusion in clinical trials. Available from: https://www.pfizerclinicaltrials.com/about/diversity-inclusion-clinical-trials [Accessed April 30, 2024] 

³ AbbVie, Commitment to diversity in clinical trials. Available from: https://www.abbvieclinicaltrials.com/resources/commitment-to-diversity-in-clinical-trials/ [Accessed April 30, 2024]

⁴ Bristol Myers Squibb, Diversity in clinical trials. Available from: https://www.bms.com/about-us/responsibility/bristol-myers-squibb-foundation/our-focus-areas/diversity-in-clinical-trials.html [Accessed April 30, 2024]