Clinical trial diversity

The need for diversity in clinical trials has come to an inflection point, with the FDA issuing draft guidance for how trial sponsors can enroll more ethnically and racially diverse patients and more companies delivering plans for achieving these goals.

Despite the increased attention and clear need, many pharma and biotech companies still haven’t shown that their efforts are working.

That’s not the case with Johnson & Johnson Innovative Medicine (formerly Janssen), which has been confronting the issue since 2018.

“This has been something that's been with us for quite some time,” said Denise Bronner, director of diversity, equity and inclusion in clinical trials at Johnson & Johnson Innovative Medicine (JJIM). “This is something — long before the FDA had released any guidance [and before] the political and social issues that happened in 2020 with COVID — the company was already starting to think about.”

The company has considered ways to make clinical trials “reflect the real world” to advance science, fill “big gaps” in research and increase access to effective medicines to underserved populations and communities, Bronner said.

“As a patient, you want to know that what you’re taking works for you,” she said. “And if someone like you was never included in the data, but this drug is approved, how would you take that? Would you even want to take that type of medication?”

Now, the company is seeing its efforts result in measurable change. For instance, it has already exceeded its goal of enrolling 554 Black, indigenous, and people of color (BIPOC) patients in six immune-mediated inflammatory disease studies by the end of the year. The pharma giant hit that milestone in July and by October, exceeded the goal even further, enrolling 853 patients who self-identified as non-white, including Black, Asian, multiracial, Native Alaskan/American and Hispanic non-white patients. Those numbers mean these patients represent nearly half of total enrollment across those studies in 2023, which far exceeds the 15% to 20% typically considered “diverse enrollment” by the industry.

PharmaVoice spoke with Bronner about some of JJIM’s strategies for success and six approaches that have been key.

Invest in education

Improved recruitment starts with awareness and education. One of the ways JJIM has tried to advance these is through Research Includes Me, a website that’s disease and trial agnostic and aims to educate people about clinical research, expectations, patient rights and community impact. It also includes a trial finder tool.

Optimize protocols 

Restrictive inclusion/exclusion criteria that limit study participants only to people who haven’t had previous exposure to hepatitis B and C or require lab results to be within a certain range can be a major barrier to recruiting certain groups of patients, Bronner said. Other elements of the study protocol, such as site frequency, can also hamper recruitment. 

Historical protocols and inclusion/exclusion criteria can be adapted and broadened to allow more diverse participation.

Improve study site selection

Instead of only considering study sites in the U.S., Canada and Europe, Bronner said JJIM has taken a global approach to improve representation. 

“We've tried to expand to have deeper ties with the Asia-Pacific region, [and looked] into Latin America and even using African nations to help with recruitment,” she said. “Having such a large country footprint has allowed us to get representation across the board.” 

And instead of revisiting the same study sites again and again in the U.S., Bronner said sponsors can use claims data alongside census data to map where target patients live and look for sites nearby “to meet the patients where they are,” she said.

Use robust recruitment tactics

Even with optimized protocols and site selection, recruitment isn’t guaranteed. JJIM works with sites to discern whether their materials and imagery reflect the kind of patients they want to recruit; provide educational materials about the trial, disease and clinical research; and train the staff around cultural competency using scenario-based training. The company also engages DEI-focused vendors that have access to and trust within communities to disseminate information.

Focus on retention as well as recruitment

Recruitment is only half the battle, and sponsors also have to make sure patients stick with them. Bronner said companies can compensate patients in many ways including transportation services, child and elder care, and connecting them with support groups. A sponsor can also provide “multiple touch points for patients,” for constant communication, such as reminding them of their next visit and answering questions. 

JJIM also contracts with vendors who provide “study buddies,” who are patients’ point of contact from start to finish. Bronner notes that although the perception is sometimes that participants of color might have higher dropout rates, the opposite is actually true. 

“We have seen that once a patient from a BIPOC community has come into our study, the dropout percentages are much lower than their white counterparts, and that is because they're finally getting the type of care they’ve been seeking,” both from the therapy itself and the ongoing check-ins with healthcare providers, Bronner said.

Understand that trust issues are not only historical

While BIPOC patients often mistrust the medical establishment, the reasons why aren’t limited to historical incidents like the Tuskegee syphilis study. There are ongoing issues impacting patient perception right now including high-profile examples of perceived challenges getting adequate care. Serena Williams, for example, suffered a medical complication after childbirth that she said was initially brushed off. 

“There are persistent things that are happening as well, so we have to acknowledge that, as an industry and as a sponsor, but we also have to demonstrate what we're doing differently to address it,” Bronner said.

Among the many falsehoods surrounding diversity in clinical trials, the notion that people of color simply don’t want to be part of drug studies is one of the most harmful, said Quita Highsmith, Genentech’s vice president and chief diversity officer.

Following a global study the biotech giant conducted during the COVID-19 pandemic that enrolled a large majority of Black and Hispanic patients, Genentech’s latest shot across the bow for clinical diversity was a trial exclusively in patients with multiple sclerosis from those communities. Genentech sells the blockbuster MS drug Ocrevus.

Highsmith, a former PharmaVoice 100 honoree, said the trial achieved a breakthrough in proving that reaching diverse patients isn’t a detriment to the science. Black and Hispanic patients make up almost 20% of the MS population but clinical studies often fall way short of that representation, according to the company.

The problem, Highsmith said, has been that trials haven’t historically been designed to accommodate the needs of these communities. So when a trial like this one — called Chimes — meets people where they are and finds common ground with advocacy groups and clinical investigators, patients receive more equitable care.

At a time when political backlash has been rising against diversity initiatives at corporations, and in education and healthcare systems, Highsmith said it’s even more important to question the status quo.

Here, Highsmith discusses the myths surrounding a lack of diversity in clinical trials, how collaboration can benefit the biopharma industry in its efforts to change and how health equity rises above political posturing.

This interview has been edited for brevity and style.

PHARMAVOICE: What are the greatest challenges to diversity in clinical trials as you see it?

QUITA HIGHSMITH: There are a lot of myths. One is that patients of color don’t want to participate in clinical research. Myth No. 2 is that, if they participate, it’s going to slow down the research, and we’re not going to be able to get the products on the market. Myth No. 3 is that patients are not going to be compliant. And these myths have meant that they have been excluded and have lower participation rates. In our research, when people of color are asked to participate, they do so at the same rate as everyone else. They want to be part of the solution. When we select sites in areas with high unmet need and populations that are going to be representative of patients of color, we’ve found that these sites are enrolling Black and Hispanic patients two times faster than other sites with the same study. If you go where the patients are and ask them to participate, they will.

These myths sound like they come from a lot of false assumptions. Can you talk about how you get past these assumptions?

One of the things we did during the pandemic was a study called Empacta, looking at hospitalized patients with COVID, and 85% of study participants came from communities of color. And what we learned was that if you go to patients, they will participate. And if you partner with sites, even if they haven’t done clinical research with us before, they are willing to work with you to overcome barriers so that you have a real-world patient population versus a fairy tale population.

Then, when we took a look at the unmet need of multiple sclerosis, we had those learnings from COVID to do this study called Chimes. The scientific question we wanted to address was that many people believed that multiple sclerosis was a disease that impacted white women. And what we know is that the epidemiology shows that Black and Hispanic patients oftentimes are disproportionately living with MS, but they’re diagnosed later. So, working with the community and Dr. Mitzi Williams, a neurologist out of Atlanta who was the lead author of the study, we were able to enroll ahead of schedule and retain those patients. And we found that safety and efficacy was the exact same as the general population, which gives organizations comfort knowing that you can bring in real-world patients to a clinical study and get a similar outcome.

With these gaps in data, how can Genentech and others in the industry use technology to improve patient diversity?

Actually, one of the areas of concern I have is artificial intelligence. The reason for that is if we look at the genome-wide sequencing database, it’s not very diverse. There’s very little data out of Africa — less than 1%. And when we think about AI using algorithms to make treatment decisions, and that algorithm doesn’t have data from people of color, we have to be very mindful that we don’t continue with the issues of the past. We’re thinking very proactively about ensuring that we have representation in the datasets we’re using. One of the things I’m excited about is the FDA’s omnibus legislation that all phase 3 programs have a diversity action plan to be considered for approval. That kind of ripple effect from the agency is going to advance opportunities to ensure patients are actually in the clinical trials.

Do you feel that Genentech’s efforts with the Empacta and Chimes studies give you a leg up with those action plans?

We’ve been working on advancing inclusive research since 2017, and as we think about the things we’ve done differently, we think about our site recruitment strategy. We think about how we engage with patient advocacy organizations, how we engage with clinical trial research organizations, and we now have in place unconscious bias training to account for study validity. I do feel like we’re better prepared to take these steps. And we’ve been writing articles and sharing it because we don’t want to hold all the secrets. We’re trying to transform society, and we have a responsibility to lead as a founder of the biotech industry.

Is there room for more collaboration in these efforts?

Absolutely. We all need to generate evidence, and a lot of startup biotech companies use the blueprint that we have because they don’t have the same resources. When we do something, it has a ripple effect across the industry.

In these politically divisive times, there’s a lot of backlash against diversity efforts. How do you promote health equity and diversity without getting caught up in the political fray?

We believe in a world where all individuals have access to the best-quality healthcare, and the work we’re doing is to include more people and be more equitable for everyone. Can anyone fault somebody for wanting to ensure people who have a disease actually have a chance to be treated? We’re not thinking about the politics of health equity. We’re thinking about how we ensure all patients have access to innovative clinical therapies and that we’re not leaving patients behind. 

We’re also not blaming patients of color because they don’t have access — we’re thinking about real solutions that can address people’s concerns. It’s not about doing things differently — it’s about doing different things. If we continue with the status quo, then we won’t have the opportunity to treat medically disenfranchised patients. I have a motto that we want to treat every patient like they’re our mother, and if we do that, we’re going to find solutions.

Court Horncastle, senior vice president and business unit head of the anti-infective and respiratory team at GSK in the United States, understands the incredible value of diverse teams.

As a U.S. Army Armor Officer leading a tank platoon through the desert in the early 1990s in Saudi Arabia and Iraq, Horncastle’s first tank crew was a living, breathing example of the power and benefits of diversity. Horncastle hailed from the New York City suburbs; his gunner grew up in Puerto Rico; his driver was a “farm boy from Kansas” who’d never left his county before joining the army; and his loader grew up in Compton outside Los Angeles. They had different levels of education and wildly different upbringings and backgrounds.

“You couldn't have taken four more different people and thrown us all together inside a tank where we lived sometimes for weeks, months at a time,” he said.

They also had different worldviews, which meant they could tackle a problem from every angle.

“We were incredibly effective because we were incredibly different,” he said. “Whatever problem or challenge or opportunity that we came across, we had a huge variance in potential solutions because we all started from a different way of problem-solving based on our backgrounds and our experiences.”

Like every industry, pharma and biotech is focused on DEI for many reasons.

“I think diversity, equity and inclusion is incredibly important because I think it's the right thing to do,” Horncastle said. “I also simultaneously think of DEI as a competitive advantage that helps me within the marketplace.”

Unlike other industries, though, the way life sciences companies need to tackle DEI is twofold. Not only are they working on it internally, with their own employees, but they also must work on it externally, by recruiting more diverse groups of patients for clinical trials.

And despite the increased attention on DEI, a report from earlier this year revealed that diversity in clinical trials has actually decreased in recent years. Here are some of the ways companies are refining DEI strategies in the workplace and for patients.

Partnerships and accountability

With the FDA calling for concrete diversity plans and goals in clinical trials, companies are taking action.

“To reach adequate levels of clinical trial diversity, the responsibility lies within the biopharma industry to raise the expectation that DEI is necessary for improved patient outcomes across all therapeutic areas,” said Melaina Boyce, head of in-country clinical study operations in the U.S., Canada and Latin America at EMD Serono, a biopharma company that specializes in infertility, multiple sclerosis and oncology.

For instance, EMD Serono established an internal Diversity and Equity in Clinical Trials Working Group that “created a template to help detail diversity plans when engaging with the FDA about our priority programs,” Boyce said. The template shows the company’s work in understanding underrepresented populations and includes details about how the company plans to attract, recruit and retain these patient populations.

One strategy is partnering with healthcare professionals and community groups.

“Currently, we’re working with trusted partners in the communities,” Boyce said. “Many of these partners — ranging from advocacy groups, to nonprofits, to networks — already have trusting relationships with these audiences, and they can help build a bridge to improve trust and access to these clinical trials through bi-directional communication.”

Other companies are taking a similar approach. For instance, Amgen is funding a nearly $1 million pilot program with The American Cancer Society Cancer Action Network to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials. And the Digital Medicine Society launched in February a suite of free resources to advance DEI in digitized clinical trials.

Companies are also holding themselves accountable internally.

“We have put an overarching DEI scorecard in place to monitor metrics and progress across the company, including an area that specifically measures our improvements in clinical trial diversity,” Boyce said. “The scorecard has high visibility within the organization, as global senior leaders evaluate the company’s progress on all relevant DEI items annually. Additionally, the scorecard outlines areas that require action to ensure we’re holding ourselves accountable to the standards we’ve set.”

The Biotechnology Innovation Organization (BIO) is among the organizations focusing on the workforce side. According to interim CEO Rachel King, they’ve just hired a new chief human resources officer, and one of his tasks is to help think through how BIO can help its members with DEI efforts. Although they’ve already started benchmarking around best practices, King said she thinks “there’s a lot more” that could be done and they’re “in the process of defining that.”

People ages 65 and older have the highest rate of chronic disease among any age group — nearly 95% have at least one chronic disease, such as heart disease, arthritis or diabetes, and about 80% have two or more. They are also the heaviest users of medication.

Despite this medical need, clinical trial enrollment of older adults remains low.

In the mid-1990s, fewer than 25% of participants in oncology trials were older adults, even though they made up roughly 67% of new cancer diagnoses and 75% of deaths. Participation in oncology trials among this age group now hovers around 30%, according to Sharmeen Roy, chief strategy and science officer at DoseMeRx, a Florida-based provider of precision drug dosing software.

That’s slowly changing, spurred by an FDA push to boost diversity in trials. The agency issued several guidance documents in recent years aimed at enrolling more adults over age 65, in addition to other underrepresented groups.

But the numbers still aren’t where they need to be, Roy said.

“I think it is improving, but there's room to grow and a lot more that needs to be done,” she said.

A critical demographic

There’s great interest in developing drugs for conditions that disproportionately affect older adults, and nearly 450 of these drugs are in clinical trials. There’s also an incentive to improve care — the cost of managing these diseases is high, making up two-thirds of all healthcare costs overall and 93% of Medicare spending, according to PhRMA.

Drugs often don’t work the same way in this age group as in younger people, Roy said. Older people may take longer to metabolize medications, increasing the risk of toxic reactions at doses that may be safe for someone younger. They may also be on medications that interact with the trial drug, Roy said, rendering many people ineligible.

One blood pressure trial in very elderly adults, for example, looked to assess whether a blood pressure treatment could reduce stroke risk in people over age 80. However, less than 2% of identified patients met inclusion criteria.

While some trials bar older adults based on their health, other exclusions are based solely on age.

“A lot of these older patients get excluded even though they're healthy adults,” Roy said.

These inclusion barriers can limit information about how medications will perform in real-life users, who tend to be older and sicker than people in research studies.

“Oncology medications have a lot of adverse effects and toxicities, so we're not fully understanding how older patients may respond to these therapies and even what may be the appropriate dosing for these patients,” Roy said

The same is true for other types of medication as well. Making enrollment criteria more flexible can help ensure that more older adults are eligible to participate, Roy said.

Inclusion criteria aren’t the only barriers to trial participation. Many older adults simply don’t know that clinical trials are an option due to insufficient outreach, despite substantial interest in taking part. More than two-thirds of older adults said they would sign up for a trial if their doctor recommended it, but research has found that doctors are less likely to offer the clinical trial option to older patients.

Older adults may also need help navigating complex logistical hurdles that may otherwise dissuade them from participating. Many elderly people need assistance from a caretaker to get to the trial site, the lab or imaging appointments. Some sites provide or cover the cost of transportation or adopt a decentralized model, using virtual visits or other strategies to lessen the burden.

“I think that can be helpful if you’re doing outreach specifically for older adults and going to them and making it more convenient,” Roy said.

Clinical trials can be stressful for someone young but are more so for people who are older or in poor health.

“It's a lot for any patient to be in a clinical trial, so you have to almost customize an approach for the elderly population,” Roy said, adding that he had to try novel solutions to keep trials moving during the COVID-19 pandemic.

“I personally had to set up a drive-through pharmacy for my research patients to pick up their medications so there were no missed doses and they could still continue with their visits,” she said. “Sometimes you have to get creative and make sure that they have the resources available.”

Providing ongoing support to patients, particularly when they have burdensome health conditions, can keep people from dropping out.

Proxy problems

Another challenge is informed consent. Those experiencing cognitive decline will need a proxy to sign informed consent forms, but weighing the pros and cons of a trial can be difficult even for those who don’t.

“I have served on a couple institutional review boards and part of the review process is reviewing the consent very closely and making sure that it's at a level where the patient can understand and it's not overwhelming,” Roy said. “That's the goal. You want to make sure they're fully understanding what they're signing up for. Because if they don't, often times you'll see you get the enrollment, they get started and then when they realize what is involved, they’ll drop out. We want to avoid that and make sure that it's truly an informed consent.”

This process should be cognizant of generational, cultural and language barriers.

“In South Florida we have a very diverse population, and we have those challenges and barriers to really understanding the benefits of clinical trials,” Roy said.

In addition to measures taken by sponsors, the push by the FDA will likely continue to increase participation among older adults. Pediatric patients also used to be underrepresented in clinical trials until the FDA pushed for inclusion.

“There were FDA guidance incentives to have those trials,” Roy said. “Now we're at the other end of the spectrum where we have an aging population.”

The country’s population of older adults is growing, so the time is right for change. Some 56 million Americans are over age 65, and that number is expected to climb to 80.8 million by 2040.

Although an estimated 1.6 million Americans identify as transgender or nonbinary, a recent Parexel report revealed that less than one percent of clinical trials in the U.S. include patients from these communities.

While the industry is making strides toward improving trial access, its efforts have largely focused on race and ethnicity, often leaving out considerations of gender identity and sexuality. For transgender and nonbinary patients, underrepresentation in these studies could determine whether a life-saving therapy will work in their bodies, or whether it will cause more harm.

“If you think about somebody who has transitioned, there are the medical issues related to their transition, but they could have chronic or acute conditions that also need to be treated,” Xoli Belgrave, senior director in Parexel’s office of the patient, said. “We can't ignore that because we're not sure what to do.”

Patients in these communities face a diverse set of health challenges related to gender-affirming care. They also disproportionately suffer from chronic conditions compared to the general population. But because they’re so rarely included in trials, there’s little evidence to be used in drug approval decisions.

Parexel and other clinical trial solutions companies are moving the needle with research programs and initiatives aimed at enrolling more LGBTQ+ patients. Still, countless obstacles remain, from rethinking the way trial protocols are written and patients are recruited, to retraining staff and offering new amenities at study sites.

Fixing the system means starting with the basics, by making trials “if not more inclusive than less exclusive,” and by adjusting study inclusion criteria and the ways data is collected, Belgrave said.

“Change is always slow. Except for those that want to change, or for those that see the value of change,” Belgrave said. “That's the first thing: Where there's will, there's change. And we've seen that.”

Inclusion criteria

Among the greatest obstacles is combating the industry’s “if it’s not broken, don’t fix it” approach to trial design, Lindsey McNair, a life sciences consultant, and the former chief medical officer for WCG Clinical, argued.

“When people write protocols, they start from their last protocol,” McNair said. “If the contraception language is fine on their last protocol, then they just cut and paste it into the new protocol. And if the database setup was fine in the last study, they replicate the database setup.”

Past protocols often include outdated language that isn’t only exclusionary, but also scientifically inaccurate. When companies reuse those protocols, they’re perpetuating lasting problems, and the only way to break the habit is to rewrite the inclusion criteria for each trial.

“It's about removing or looking at the criteria and saying, ‘Do we really need this? Why is this here? Is there a scientific or safety reason for these criteria?’” Belgrave explained.

For instance, in a trial for an ovarian cancer drug, an inclusive protocol would allow all patients with ovaries to participate, rather than just people who identify as female by sex or as a woman by gender because nonbinary individuals and trans men can also have ovaries.

Inclusivity issues also frequently arise around contraception and pregnancy testing criteria. Not all women may have sex with a person who can get them pregnant, but if they’re not using a form of birth control, they still may be excluded from some trials because of rigid language.

“If you're saying we have to exclude a group of people because there might be a safety risk, then exclude the factor that creates the safety risk and not the people,” Belgrave said.

Similarly, in studies that need to exclude patients taking hormone therapy or other gender-related treatments for safety reasons, McNair suggested writing the protocol “so that it excludes the medications that are of concern and not the people” to avoid overly broad guidelines.

In cases where safety is a consideration, however, allowing patients to make an informed decision about whether to participate may be a better course of action than making that decision as an institution.

“When people are asked, ‘What's most important to you? Is it your safety? Is to being allowed to participate in the study?’ … they say both,” Belgrave said. “My question then becomes, how do you do that in a litigious environment — honoring people's right to participate, while acknowledging that there may be adverse events?”

The solution is to let the participants choose their risk, Belgrave said.

Next steps

Some progress is already being made to understand how patients receiving gender-affirming care may react to other drug treatments. While including transitioning patients in early-stage trials continues to pose obstacles, organizations can conduct post-market studies.

“That's a safe space to start because you already know that there's a safety profile for that medicine,” Belgrave said, noting that more research into the diverse experiences of the trans community is also necessary.

“We have to remember that transition looks different to each individual — not all transitions are chemical, not all transitions are surgical and not all transitions are the same. For that reason, there should be some kind of work to assess: can this be compared to something else?” Belgrave said.

Getting to the next phases of research also will require support and Institutional Review Boards, McNair argued. Eventually, the hope is that IRBs will begin rejecting study designs that are not inclusive or scientifically accurate based on current knowledge of gender and sexuality, McNair said.

However, to get to that point, Scott Hunter, former vice-chair of the University of Chicago’s Medicine and Biological Science division’s IRB, said the FDA also needs to release some guidance on the topic.

“A lot of what happens for members of the IRB, is that there has to be a very strong understanding of where current policy is from the FDA, and then how do we ensure that a study is being read in a way that's going to meet that,” Hunter, who now serves as a senior scientific expert at WCG Clinical Research Solutions, said. “If the policy isn't changing to allow for the diversity that's necessary, then that study is going to be less successful.”

For Belgrave, waiting for that FDA action isn’t an option.

“It's up to us as an industry to pick up the ball and proactively start to implement some of those things that we've talked about in thought leadership,” Belgrave said.

When Ricki Fairley pictures the perfect clinical trial site, she imagines “a beautiful Victorian house on a street in a Black neighborhood” with a wrought iron gate in the front, nudged open just a few inches. On the front porch, a Black grandmotherly figure welcomes patients with a hug, takes their children to a playroom and feeds them spaghetti. She then takes the patient to a treatment room with a comfortable chair, a hand-crocheted blanket and a cup of tea with fresh mint from the garden out back. The soul tunes of Luther Vandross play softly in the background, as Black physicians move in and out of the room.

In her “ideal world,” Fairley would build such a house “in every Black neighborhood in the top 10 cities” across the U.S. to increase clinical trial enrollment among the Black community.

While she has yet to realize that vision, as the CEO and founder of Touch, The Black Breast Cancer Alliance, an advocacy organization aimed at decreasing the breast cancer mortality rate for Black women, Fairley is working to improve the dismal, yet all-too-familiar trial participation statistics. And as a survivor herself, she’s particularly focused on helping Black women.

The Black participation rate has declined consistently over the last decade — falling almost 3% just between 2020 and 2021, a report from the IQVIA Institute for Human Data Science found. And those numbers have real health-outcome consequences.

In breast cancer, for instance, Black women make up less than 3% of clinical trials and have a 71% higher risk of death and 39% higher recurrence rate of breast cancer than their white counterparts. The dearth of data on how the disease and its treatments impact Black patients accounts for some of the discrepancy in outcomes, Fairley argues.

“When you look back in history, there were no Black women in the clinical trials for the drugs that we have as standards of care. For Cytoxan, Adriamycin, Taxol, Taxotere, Herceptin — there were no Black women,” Fairley said. “They're not working to the extent that they should. We need drugs that have been tested on our bodies.”

Still, even with recent FDA guidance that makes diversity a “must have” in clinical trials, pharmas are failing to enroll representative demographics and Fairley doesn’t see anything changing unless the industry completely reimagines its recruitment tactics.

“Pharma hasn't known what to do yet.” she said. “It's hard to get everybody into trials, but they can't get Black women because they're not talking to them the right way.”

What exactly needs to change? Well, according to Fairley, everything.

Fear of the unknown

For starters, the industry needs to begin breaking down the emotional barriers to trial enrollment, she said. While companies are beginning to tackle physical barriers — like location and transportation —these efforts aren’t likely to bear fruit if patients are still weary of science and the medical industry. And chief among the emotional barriers for the Black women she works with is a fear of the unknown.

“They don't understand how the science works. They say ‘I'm gonna get the sugar pill and die.’ And so they're afraid of being a guinea pig,” Fairley said, noting that much of the time “their only reference point is Henrietta Lacks, or the Syphilis study.”

But quelling these concerns is a matter of explaining the science and impact of trials in everyday terms. When Fairley speaks with patients on a personal level and explains that everything from a dog’s heart medication to Advil to cancer medications were once tested in clinical trials, they begin to get it. Then, when she tells them that they’re going to get a medication — whether it’s the standard of care or new drug candidate — they’re even more on board.

Of course, the other major piece of the puzzle is who is relaying the message. Familiar faces, like the Black grandmotherly figure at the door in Fairley’s dream world, are integral.

“They don't trust doctors; they don't trust researchers. They trust other ‘breasties,’” Fairley said of the patients she works with. “Right now, they're going to Dr. Google and they're seeing pronouns like ‘you’ and ‘they.’ When they come to our site, the pronouns are ‘we’ and ‘us.’”

The small difference in language lets the patients know that they’re rather part of a broader movement. Touch extends that message by exclusively featuring Black breast cancer survivors in the informational videos on its site so that patients are hearing the message from people who not only look like them but have been in their shoes.

However, for representative messaging to work, it must be carried through all materials. For instance, Fairley pointed to a Big Pharma campaign on Facebook for a pneumonia vaccine that “had these beautiful ads with a cute little Black couple and the beautiful Black ladies,” but then linked to a website exclusively featuring images of white patients.

“It's like bait and switch. I immediately lost trust because they weren't intentional about their message,” she said. “My question in these campaigns is ‘What's Black about it?’ You've got to show that you really care about the audience and are willing to invest in it.”

A community affair

Changing individual patients’ minds might not be enough. After all, when a patient decides to enter a clinical trial, their whole support network also needs to be on board with the decision. And when mistrust is pervasive, that’s a lot more difficult.

“Even when a patient brings up a trial to a doctor, she still walks away not being informed enough to convince her family that she should do it,” Fairley explained. “She's convinced, she goes home and her mom says ‘You're gonna get the sugar pill.’ And she can't explain to her mom how the science works, so she changes her mind.”

To combat such scenarios, Touch began running a radio ad on hip-hop stations in 10 major cities targeted at young Black women “to make them aware of the science and have them start these conversations at home.”

Data on that specific campaign is murky, but anecdotally Fairley said the organization received countless calls from women asking if they could sign up for a clinical trial, and many of them hadn’t even been diagnosed. It’s just one sign that Touch’s tactics are working, she said.

Since its founding in 2020, Touch has enrolled over 8,700 Black women in breast cancer studies. And Fairley’s already been asked to extend the work into other areas.

“I do believe that the issue of (a lack of) knowledge about clinical trials is the same (across disease areas),” she said. “People always ask me, ‘What are you going to do next? Can you come to Africa? Can you talk to Latinos? Can you do heart disease?’”

And while Fairley remains steadfastly focused on reaching her goal of “mortality rate parity” for Black women, she said if the industry adapted similar tactics and made clinical trials seem as comfortable and safe as visiting a neighbor down the street, recruitment numbers across indications might finally look different.

One of the major challenges with clinical trials is that they don’t necessarily reflect what happens in the real world and instead rely on a subset of the population with inherent biases and limitations. As technology improves, the life sciences industry can begin to lift the veil that keeps those restrictions in place, giving companies the tools to quickly identify a more diverse group of potential participants.

A lack of diversity in trials can also have implications down the road for the regulatory and commercial success of a drug, with millions of dollars at stake, a phenomenon seen clearly in the case of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm.

A few years ago, the idea that clinical trial recruitment could check this box sounded like an insurmountable obstacle. But over the last couple of years, pharma companies have started hiring talent to specifically oversee diversity and inclusion in clinical trials, and investing money and energy into the effort. The FDA has also applied some pressure in this area, most recently with a draft guidance designed to encourage participation among historically underrepresented groups.

The needle is beginning to move in the right direction, says Ariel Katz, co-founder and CEO of the healthcare data and analytics company H1.

“How achievable is (diversity) today? A lot more achievable,” he says. “And in five years, I think it'll be so core to how they think about enrollment of patients and enrollment of (principal investigators) and physicians that it's going to be possible.”

But while progress is being made, finding participants remains a central challenge. That’s where technology comes into play, Katz says.

Lack of diversity, substandard results

Historically, trial participants have been pulled from the same buckets linked to the academic medical centers where trials take place, leaving out members of the broader community.

When drugs or treatments aren’t tested in a group that represents the true patient population, that can skew the results and lead to unexpected or undesirable surprises when the drug hits the market, Katz says.

One size doesn’t fit all when it comes to drug safety and efficacy. Genetics plays a role in how different populations respond to a specific drug — a lack of diversity in the development process might mean the drug doesn’t perform as well as expected or has unforeseen side effects when it rolls out to the broader population, Katz says.

Take Biogen’s ill-fated Alzheimer’s drug, Aduhelm. While many issues plagued the controversial drug, which had significant coverage sidelined by Medicare’s decision not to pay for the treatment outside of approved clinical trials — a lack of diversity in its clinical trials was likely also a factor, Katz says.

According to the Alzheimer’s Impact Movement, Black Americans have nearly double the risk of developing Alzheimer’s when compared with white Americans. Hispanics have about one and a half times the risk. But these groups were sorely underrepresented in Aduhelm’s trials. Less than 1% of participants were Black, and only 3% were Hispanic.

The FDA is now requiring Biogen to complete a more diverse new post-market confirmatory study to provide additional safety and efficacy data, which Katz says will likely add millions to drug development costs. The average post-market central nervous system trial costs $14 million, according to H1.

Aduhelm isn’t an outlier.

“This example is very representative of what you see across the entire industry,” Katz says.

Building a better trial

Every trial population should reflect the patients with that condition, Katz says. Technologies like H1’s global platform can help recruiters find them.

“Today we have about 10 million healthcare professionals on our platform, and we’re used across the whole healthcare ecosystem — from patients finding the right doctor, to a life sciences company finding the right doctor to run a clinical trial, to a payer finding the right doctor to insure and put in their health plan and network,” Katz says.

Locating the data is crucial to zeroing in on the right participants.

“Today, H1 is able to give a pharma company the race and ethnicity of every single patient that a doctor sees,” Katz says. The information is compiled using demographic data, self-reported patient data and information from partnerships with other sources. Recruiters can search by location to identify doctors that may treat the target group of patients.

For example, a search of Boston providers could identify a doctor who treats bladder cancer and has a higher percentage of Black or Hispanic patients. It also allows recruiters to see information about social determinants of health, such as patient income, education, or other factors.

“It lets me look at patient population before I actually reach out,” Katz says.

Having this information can have a tangible effect on recruitment. In some instances, users have seen as much as a 60% increase in the selection of diverse patients and physicians by using the platform, he says.

Keeping participants requires work

But Katz says it’s not enough for researchers to simply identify the right mix of people — organizations also need to ensure that the proper supports are in place to encourage participation and retention. One of the biggest challenges trials today face is building trust with historically underserved groups.

“If you have people that look like you and talk like you and that you can relate to … or you have a doctor that looks like you, or talks like you, it helps. You trust them more,” he says.

Language is another important consideration. H1 also helps to match people with providers that speak their language. Trials haven’t always done a good job accommodating non-English speakers.

Organizations should also look to meet participants where they live by adopting a decentralized trial model, Katz says.

“Walgreens and CVS just started running clinical trials. There’s a Walgreens and CVS in almost all communities,” Katz says. H1 is helping them find investigators to oversee these trials. Bringing trials into a familiar setting rather than making people travel can make research more convenient and appealing to a broader group.

Ultimately, building diversity into a trial requires commitment and investment.

“I would invest more into patient advocacy groups that have diverse patient populations. I would invest more into internal processes and communication and making sure that you’re actually reaching diverse communities, making sure you are finding physicians that see low- and middle-income patients,” Katz says.

Eventually, H1 would like to broaden its tools to include even more detailed information, such as an expertise in LGBTQ-related care, or whether buildings are wheelchair accessible.

“We don’t have that today, but we're working to get that, which we believe is the next generation of what patients need and what sponsors need and what life science companies need when they're thinking about enrolling patients,” Katz says.