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.

Sponsored content

By Scout Clinical

Clinical trials are the foundation of modern medicine, yet a significant portion of the patient population is underrepresented. Improving clinical trial diversity is not only about equity; it's about ensuring treatment safety and efficacy for everyone. Read on to understand why an eye to inclusion is critical–and how outsourcing patient support helps optimize trial retention through patient experience.

Trial diversity: definition & impact

In the context of clinical research, diversity refers to the inclusion of participants of various lived experiences and characteristics like age, sex, gender, ethnicity, sexual orientation, and race–the combination of which has a significant impact on health outcomes.

Increasing diversity among trial participants is a major focus of today’s clinical research, and its benefits are numerous. More diverse trials can:

• Improve drug safety and efficacy. By testing drugs on a diverse population, researchers can identify any group-specific reactions or benefits.
• Promote healthcare equity. Trial diversity helps ensure that all populations (including underrepresented ones) benefit from clinical research, reducing health disparities.
• Enhance quality of research. Diverse clinical trials contribute to scientific validity and reliability since findings can be generalized to a larger population.

Challenges to optimizing trial diversity

Despite these advantages, clinical trial sites often face significant challenges in recruiting a diverse population: cultural and linguistic barriers, mistrust in medical research, and logistical issues like transportation and scheduling which limit the participation of underrepresented groups.

Though an in-house approach to coordinating patient travel, transportation, and reimbursement may seem appealing from a budgeting perspective, it’s not always ideal or effective. In fact, it can introduce additional strain on an already complex process, potentially compromising the efficiency of the trial and the level of patient care due to the diversion of critical resources away from their primary research and clinical responsibilities.

Partners in patient experience

One effective way to remove barriers to participation is utilization of third-party clinical trial patient service providers, who are uniquely equipped to address these challenges with a specialized focus and expertise in patient travel, payment, reimbursement, and logistical support for hard-to-reach patient populations.

Dedicated service providers like Scout Clinical are uniquely positioned to enhance recruitment and retention of underrepresented or hard-to-reach patient populations. They often have established relationships with local providers (and in Scout’s case, global compliance expertise), allowing them to overcome geographical challenges and reach patients in remote areas. Their bespoke services are designed to accommodate patients' individual circumstances, and their technological capabilities enable communication and coordination with patients even in remote settings.

Real-world application

In one study, Scout Clinical’s coordination of specialized quality transportation in hard-to-reach locations made participation more accessible to patients in remote areas. A mobility-impaired patient living in a remote area of Brazil was apprehensive about safety during the long-distance transport to the airport and potential flight connections that would be required to reach the hospital in São Paulo, Brazil.

To meet this patient's logistical needs and emotional concerns, Scout Clinical's Patient Liaison team coordinated with local partners to provide safe, monitored transportation for the 10-hour journey to the airport. Additionally, Scout searched all available airlines and routes to find a direct flight into São Paulo to reduce burden on the patient during travel.

Scout’s flexibility to accommodate patient needs, international expertise, and ability to provide services on a patient-by-patient, visit-by visit basis removed barriers to participation and enabled this patient to access valuable care options. Furthermore, Scout’s navigation of these challenges

reduced site burden and allowed site staff to devote more time and energy to patient care and research efforts.

Conclusion

Increasing diversity in clinical trials is critical to generating reliable, universally applicable data and developing medical interventions that serve all populations effectively. However, potential barriers such as geographical location and personal circumstances can limit patient participation and thus risk skewing the patient pool. Partnering with service providers like Scout Clinical can remove these barriers and prevent patient attrition by making clinical trial participation more accessible.

Strategically outsourcing patient services like travel and payments helps ensure that every potential participant is given a fair opportunity to contribute to clinical trials, leading to greater diversity in patient representation, more inclusive and robust data, and better health outcomes overall.

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.

Throughout the history of medical studies, trial participants have been overwhelmingly white — a situation that has long led to skewed results and diverging health outcomes in the U.S.

During the pandemic, these disparities were thrust into the spotlight as Black, Hispanic, and other ethnic and racial groups experienced higher rates of COVID-19 cases and deaths compared to white people. Yet, these groups were still underrepresented in vaccine trials for the virus.

The Kaiser Family Foundation reports that although white people make up about 73.6% of the U.S. population, they accounted for 81.9% of participants in the Pfizer-BioNTech vaccine trials and 79.4% in the Moderna trials.

Conversely, 12.3% of the U.S. population is Black, but Black people made up only 9.8% and 9.7% of participants in the Pfizer-BioNTech and Moderna trials, respectively.

However, there are many nuances within these statistics, according to a report from the IQVIA Institute for Human Data Science.

For example, the report shows that although clinical trials generally have a disproportionate number of white participants, Black/African American and Hispanic patients are over-represented in phase 1 studies compared to the overall population.

The report authors point to a range of possible factors to explain the discrepancy — including socio-economic drivers such as higher payments for participants in phase 1 trials and the locations where the trials are conducted.

The report also shows that despite the recent attention on clinical trial diversity, it has actually decreased — not increased — over the past decade among Black/African American participants. After hitting a peak of 12.3% in 2013, the Black participation rate has declined consistently over the last decade. Between 2020 and 2021 the rate fell from 9.8% to 6.5%.

While the numbers look grim, the authors note that this apparent drop may actually have more to do with an improvement in participation reporting — rather than a decrease in participation. Either way, the main takeaway remains: Clinical trial participation often doesn’t reflect the country’s patient population.

Enrollment discrepancies

In addition to differences between phase 1 and later-stage participation, the report also shows different levels of diversity by therapeutic area. In some phase 2 and 3 trials completed in 2020 in hematology, infectious diseases and psychiatry, Black patients were overrepresented compared to U.S. demographics. Conversely, Black patients represented less than 5% of the enrollment in allergy, oncology and respiratory trials.

More Hispanic patients participated in hepatology, endocrinology and infectious disease trials compared to other U.S. demographic groups, but were significantly underrepresented elsewhere.

In April, the FDA issued draft guidance for drug developers to create concrete plans to enroll more trial participants from underrepresented racial and ethnic populations. The guidance recommends that trial sponsors develop and submit a Race and Ethnicity Diversity Plan to the FDA early in clinical development, based on a framework outlined in the guidance. 

“They will be expected not only to understand potential equity barriers but to explain what they’re doing to overcome them for their product in development,” Aman Khera, the global head of regulatory strategy at Worldwide Clinical Trials, told PharmaVoice last year.

According to the FDA, many factors affect lower participation among minority patients, such as mistrust based on past abuses, which often stem from incidences like the Tuskegee syphilis study that enrolled Black men who were not informed about the nature of the research and were intentionally not treated for their syphilis. The study resulted in the death of more than 100 participants.

Other barriers include issues like lack of transportation, limited healthcare access and literacy, and location and time constraints.

In addition to guidance from the FDA, Congress is also attempting to act. Tucked within its omnibus spending legislation is a provision to require drug and device sponsors to submit diversity action plans, which echoes the FDA guidance, JD Supra reports.

In the meantime, though, the IQVIA Institute report authors write that researchers have “significant opportunities” to improve diversity through concrete plans, clear goals, and measuring results using transparent metrics.

Imagine this: You’re newly retired and are ready to become a “snowbird,” spending your winters in sunny Florida and your summers in the northern U.S. Then, you receive a diagnosis for a disease with a treatment that is enrolling patients in clinical trials near you. However, to participate, you would have to trade in your flip flops for snow boots indefinitely.

It’s a problem that’s more common than you might think, David MacMurchy, CEO of the clinical research solutions provider Lightship, said. Geographic barriers like this can often deter people from enrolling in clinical trials — and it’s one reason many in the industry have turned to decentralized study models, which allow for enrollment of a more diverse patient pool who might not otherwise be able to participate.

It's also one of the key barriers to trial access, FDA Commissioner Robert Califf said during the Milken Institute’s Future of Health Summit in early December, noting that it particularly limits participation for people in rural areas.

“If you live in a rural place three hours from the nearest endocrinologist and you have hard-to-treat diabetes, that's a big problem,” he said.

Many in the industry are attempting to close this gap by making it easier for patients to access trials in their day-to-day lives. Earlier this year, CVS Health inked a partnership with the decentralized clinical trials software company Medable to help patients enroll and participate in trials right at the pharmacy counter, and Walgreens launched a similar clinical trials business with partner Pluto Health in June.

Lightship is taking a slightly different approach by meeting patients where they are — literally. Self-described as a “virtual-first” clinical research provider, Lightship aims to design accessible trials using hybrid designs that cater to patient needs. In some instances, it even uses tour-bus-sized “mobile research units” to bring the clinical site directly to patients who might otherwise not be able to participate in a trial that could not be conducted virtually.

In pursuit of its goal, Lightship announced a partnership with the digital health company Acclinate earlier this year to improve engagement among communities of color in a neurology clinical trial — a move it hopes could lead to longer lasting relationships with the groups it serves. The collaboration leverages Acclinate’s #NowIncluded diverse digital community and Lightship’s trial design approach to enroll and retain patients in the trial.  

Here, Scott and MacMurchy discuss the company’s approach to eliminating barriers in trial enrollment, how it’s building trust within communities and why developing long-term, care-based relationships with trial participants is important.

This interview was edited for brevity and style.

PHARMAVOICE: Tell me about Lightship’s virtual-first approach.

David MacMurchy: We think about three main areas that are important. So, access — and access is defined as you can live anywhere and be in a clinical trial. Historically, and largely today, if you don't live near a site or a clinic, it's really hard for you to get onto a trial and that plays out in a number of different ways.

The second thing is virtual first supports choice, which is (about) where you can receive your trial treatment. Within the restrictions of the (trial) protocol, can you receive the treatment in a clinic, can you receive it at home, or can you receive it in a third place — a mobile unit, a local community center, or a room in your place of work if that's convenient?

If you create access for all patients, regardless of where they live and you create choice around when and where they can receive your trial, our thesis is you start to drive a real increase in diversity and deal with the equity challenge that exists in clinical trials. Today, that equity challenge is summed up as basically the lowest socioeconomic people do not have access to clinical trials and the disproportionate number of people of color in the lowest socioeconomic profile means that if you're poor, and you're a person of color, it's much harder for you get access to clinical trials. That's what we're trying to solve.

How does the mobile research unit fit into that?

Rachael Scott: Many people actually don't want someone coming into their home but then, equally, the (clinical or academic) site is geographically too far from them. This is about being able to create an extension of that site and take it into a community where people can go to somewhere that is a high-grade, clinical-fitted unit and feel that they're part of something, feel that they're respected by just the way in which the unit was set up. But it's not in their home, so it's closer in proximity but it's not overstepping the mark.

MacMurchy: The other component, which we're piloting right now, is reaching out to communities where they are. If you think of populations who have historical mistrust in the system, being able to go and work with those communities — the community leaders and nurses — and building more trust and access to those populations is something that we're very excited about.

How do you build trust with communities that might have a historical distrust of the healthcare system? What is that process of working with those community leaders and working with patients like?

Scott: The process isn't fast. There's no silver bullet to this.

MacMurchy: I think that's a really good point. Everyone thinks we should just be able to do something and turn it on and make it work. But it is years and years of history and that takes a long time to correct. When we think about this, and part of the reason we are working with Acclinate as partners, it's about building long-term relationships in communities. I think if we go into this and say, ‘We're going to go to these communities to find people to be on our trial,’ that is absolutely the wrong way to think about it. The right way to think about it is: We want to create access to innovative medicines for all the population. And we want them to feel comfortable. We don't ask, ‘Do you trust us? Do you trust the system?’ We say: ‘Do you feel comfortable with this?’ And I think that's really meeting people where they are.

How do you create that comfortability with trial participants?

MacMurchy: Two things are important. No one should be left behind. We're not coming in to help you and then leaving. When I first started in this (field), they would call (trial participants) subjects by randomization. And then we started talking about ‘Well, you know, they are patients.’ Ultimately, whether you're a subject of randomization or a patient, you're a person. We're putting drugs into people, who happen to be patients, who happen to be randomized subjects in a clinical trial. If we use language like ‘You're a subject,’ and ‘We're going to randomize you in this clinical trial,’ it just feels so cold and it's got all the wrong connotations. I think understanding the language that fits with populations is really important.

One of the things that we do for that is, our nurses act as the patient contact through the study. When a patient says they want to be on a study with Lightship, one of our nurse coordinators contacts them, and that is the single point of contact for that patient all the way through the study. So the person who turns up at their home, the person who meets them in the mobile research unit, the person who speaks to them on the phone, the person they can contact through the app, it remains that same person. I think one of the reasons we have such high rates of people feeling comfortable by being in a Lightship study is because of that. We've really focused on how we create the continuity of care through the clinical trial to build that comfort with the patient populations.

What does it look like to build these long-term relationships?

MacMurchy: When we think about long-term care and infrastructure, it's not necessarily Lightship. What we're seeing is more clients recognizing that there is a moral obligation to continue care post trial. We're trying to achieve a shift, which is serving underserved populations or low socioeconomic patients. If you're incredibly wealthy, and you're on a clinical trial and the trial ends, you have the insurance to continue to pay for that care. If you don't have the insurance that covers that care when the trial ends because you're in the lowest socioeconomic profile, there’s a real challenge there. We're really excited about working with (clients) on thinking about long-term care programs, post-trial treatment, and that's working with the community, it's working with pharmaceutical companies, it's working with insurers, you know, it's a much bigger thing than Lightship. It's something that as an industry and a world we need to address as a moral obligation to continue that quality of care for patients.

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.