Clinical trial diversity

The word “diversity” has become a political hot potato in the U.S. as the Trump administration ramps up its assault on DEI-related policies. For pharma, the stark regulatory shift has collided with major business initiatives already set in motion.

While many of the anti-DEI directives from the White House are aimed at hiring practices, the stakes go deeper for pharma, especially in the realm of clinical trials.

In recent years, the industry has been loud and proud about its quest to bring more diverse patient populations into R&D — a goal tied to the longer-term aim of improving health outcomes. Now, regulatory uncertainty has chilled the conversation, with companies stripping the word “diversity” from annual reports or opting for terms like “representation” instead. 

The removal of the FDA’s draft guidance on clinical trial diversity from the agency’s website, followed by its reappearance — with a note that the agency and administration “reject” it because it’s “disconnected from the immutable biological reality that there are two sexes” — has injected even more uncertainty into the situation.

“[Diversity is in] a moving state in the U.S. … and there are many mixed signals,” said Aman Khera, president of TOPRA, an organization for professionals in regulatory affairs. 

Still, individual pharma companies haven’t publicly wavered from clinical trial diversity aims just yet. 

“The regulated industry including sponsors and research organizations remain committed to diversity and inclusion because there is strong evidence that having a more representative population in trials is good science, it’s good ethics and it’s good business,” Doug Peddicord, executive director of the Association of Clinical Research Organizations, a trade group that represents clinical research and technology organizations, told PharmaVoice in February.

Now, the challenge is figuring out how to navigate these uncertainties while still moving forward on past promises. 

Regulatory pain points 

At the Summit for Clinical Ops Executives last month, one question kept popping up from pharma companies designing upcoming trials, said Kim Ribeiro, chief client officer at Inside Edge Consulting. 

“Up until this point … you could only be in two camps. You proactively submit a diversity plan or wait and see,” she said. “So the question has been: Do we keep proactively submitting it for feedback now that we’re not sure what’s going to happen? Or do we just write it, hold it and wait to see if the FDA is going to ask for it?”

For now, Ribeiro said the common advice for companies has been to “stay the course” with what they were already doing as the agency’s new leadership settles in.

Even if companies eventually aren’t required to submit diversity plans, they can still maintain those strategies to “ensure the science does not stop,” Khera said.

But this particular pain point adds to the existing complexity around implementing diversity plans.

“Companies are not simply facing general uncertainty but are challenged by very specific gaps and inconsistencies in policy and regulatory frameworks,” Khera said.

In particular, Khera pointed to the absence of clear benchmarks for diversity targets. 

“Regulatory guidelines from the FDA often lack specific numeric targets. This leaves sponsors to interpret what constitutes adequate diversity based on the context of their indication, geography and trial phase,” she explained. “Adding to the complexity is the variation in how race, ethnicity and other demographic variables are defined across jurisdictions.”

When companies move ahead with diversity plans, issues can crop up quickly in the patient enrollment process.

“Regulators are placing growing pressure on sponsors to modify recruitment strategies in real time if diversity targets are not being met. However, the lack of clear regulatory guidelines for adaptive enrollment creates a challenging situation,” Khera said. “Companies must balance the need for flexibility with the risk that mid-trial amendments could prompt additional review or delay submissions.”

The FDA’s guidance has also failed to keep pace with the industry’s technology innovations, leaving questions around how companies can blend inclusivity goals with data collection capabilities and decentralized clinical trials. For example, while DCTs are promoted as a fix for recruitment, how the FDA will gauge the quality of data from trials conducted remotely is still unclear.

“This creates conflicting pressures for sponsors who must adopt these models to enhance diversity while navigating unclear regulatory expectations around data integrity, patient monitoring and privacy,” Khera said.

Where does pharma go from here?

Although the FDA’s clinical trial diversity guidance doesn’t close many of these regulatory gaps, it does provide a roadmap for crafting inclusion plans.

The guidance was expected to be finalized by the second half of the year, but the agency’s stance has left its fate up in the air. On rare occasions, the FDA has scrapped proposed guidance altogether, and if that happens in this case, companies would be left “without clear instructions on how to meet requirements” mandated by the DEPICT Act passed in 2022 to promote clinical trial diversity. 

“The DEPICT Act … represents a step toward stronger enforcement,” Khera said. “Still, the effectiveness of this mandate will depend on how rigorously the FDA monitors compliance and addresses non-adherence.”

In the absence of clarity from the FDA, it’s up to the industry to keep inclusivity at the forefront.

As companies work to ensure clinical trial diversity, Khera recommends they solidify recruitment strategies by forging “stronger ties with community organizations” that boost trust and access, and leverage digital tools and tailored outreach plans to reach different patient populations. 

Companies can also create their own monitoring and reporting metrics to measure recruitment success. And publishing that data will “drive accountability and continuous improvement,” Khera advised. 

In addition, pharmas should continue to invest in training for cultural competencies, design patient-centric trials and keep diversity as a “core value” in the company’s ethos. And when going global with their trials, sponsors can take cues from other regulators, such as the U.K.’s Health Research Authority, as well as its Medicines and Healthcare Products Regulatory Agency, which published draft guidance last year and are piloting a program for submitting inclusion plans.

Engaging with the FDA could also help the agency shape future diversity rules.

At the recent SCOPE conference, Ribeiro said company leaders expressed their intent to keep up the work, even if they don’t know what diversity regulations will look like. She predicted it will be months before the dust settles from changes at the FDA, allowing companies to “see the trends” in the agency’s thinking.

Even without FDA guidance, Khera said diversity goals aren’t likely to disappear. 

“The work does not stop here. There is much to do,” she argued. “Albeit a little quieter, I see a commitment in the industry that’s there and is not going away.”

A string of executive actions issued by President Donald Trump during his first weeks in the White House triggered widespread uncertainty across government agencies. 

Some orders have been particularly impactful in healthcare.

After Trump took office, the White House issued a freeze on communications from health-related agencies, which rippled through a number of federal initiatives. The National Institutes of Health, for example, canceled a meeting on antibiotic resistance.

Meanwhile, in some ways, the FDA has been going about business as usual. The agency issued several drug approvals last week, for example, including the first nod for a new type of pain medication in decades.

Yet other aspects of the FDA’s work appear up in the air.

A Feb. 5 adcomm meeting to discuss new post-marketing rules for opioids is now missing from the agency’s calendar, and no public update has been offered about when it will be rescheduled. 

The Trump administration’s anti-DEI sweep of the government could be impacting the agency as well.

After the White House issued an executive order to end “radical and wasteful government DEI programs,” the FDA’s draft guidance on ensuring diversity in clinical trials was removed from its website. Other FDA guidance documents, such as recently published draft guidance for the use of AI in drug development, remain in place. 

No explanation has been given for why the DEI-related guidance has been stripped from the FDA’s site, and the agency did not return a request for comment. 

A statement issued by the law firm Crowell & Moring called it “highly unusual” for the FDA to revoke guidance without a public explanation. 

Given how entrenched DEI strategies have become in pharma, the agency’s sudden pullback is not likely to deter drugmakers’ ongoing efforts to increase diversity in clinical trials, according to Doug Peddicord, executive director of the Association of Clinical Research Organizations, a trade group that represents clinical research and technology organizations.

“The regulated industry including sponsors and research organizations remain committed to diversity and inclusion because there is strong evidence that having a more representative population in trials is good science, it’s good ethics and it’s good business,” he said. “It’s hard for me to suggest that there would be any movement from that position.”

Will clinical trial diversity remain safe? 

While the Trump administration’s anti-DEI push largely aims at hiring practices, the term holds a different significance in the context of clinical trials, where efforts to broaden representation are thought to produce better health outcomes. 

Educating incoming administrations about the nuanced impact of their policy initiatives is par for the course during a transition. As Peddicord monitors ongoing changes at the FDA, he said ACRO may ultimately have to work with legislators to illustrate the importance of clinical trial diversity in pharma.

“It’s incumbent on us [in] the industry to help educate the incoming administration around the importance of DEI and the widely recognized importance of better represented populations in clinical trials so that treatment populations are more reflective of the participants in clinical trials,” Peddicord said. 

The final guidance on clinical trial diversity was slated to be issued by June. During his Senate confirmation hearings to be head of HHS last week, Robert F. Kennedy Jr. said he would commit to finalizing those rules. 

Peddicord also pointed out that the core tenets of clinical trial diversity were codified into law by the Diverse and Equitable Participation in Clinical Trials Act.

Passed in 2022, the DEPICT Act stipulates that clinical trial sponsors establish enrollment goals based on age, sex, racial and ethical characteristics, explain the rationale for those goals and create a strategy for execution. 

As the situation plays out, Peddicord said he’s also keeping an eye on whether other areas of the FDA’s work remain intact — in particular, its history of communicating directly with the industry through listening sessions. 

“[The healthcare communication pause] causes some level of concern around continuing these conversations because they are important to both sides,” he said. “The ability to consult with the regulatory decision maker is a huge strength of the system.” 

Despite the uncertainty, Peddicord said he believes clinical trial diversity initiatives will be safe — for now.

The anti-DEI movement had been sweeping across America for years — and it was just a matter of time before it crashed into pharma. 

For Kim Ribeiro, former head of diversity and patient inclusion at AbbVie, the shift became apparent following the U.S. Supreme Court’s decision to overturn affirmative action in higher education last year.

"After the Supreme Court ruling, some conservative activists launched efforts to challenge corporate programs involving race- and ethnicity-based grants and funding," Ribeiro, now the chief client officer at Inside Edge Consulting, a multicultural community programming firm, explained. "This included threatening litigation against law firms with DEI programs across the country, who in turn began advising their corporate clients, including those in the pharmaceutical sector. 

The pressure on corporations and other organizations to dismantle diversity initiatives hasn’t let up.

Walmart joined a growing number of large companies buckling to the DEI backlash when it confirmed plans to roll back several diversity-aimed strategies including support for the philanthropic Center for Racial Equity launched in 2020 by Walmart’s CEO. 

And with president-elect Donald Trump preparing to return to the White House, several of his MAGA allies are now planning to launch an investment fund to back companies that eschew DEI policies. The fund’s CEO, James Fishback, is a long-time investor and buddies with Vivek Ramaswamy, the former biotech entrepreneur turned presidential-hopeful who’s been tapped by the Trump administration to tackle government waste alongside Elon Musk, Axios reported this week.

While many of the “anti-woke” attacks have focused on corporate hiring practices and college admissions, several leaders have spoken out about the risks of these efforts creeping into healthcare. 

“I fear that the possibility of even more DEI bans will have grave side effects for our healthcare system,” Lilian Bravo, an assistant professor at University of Miami’s School of Nursing and Health Studies, wrote in an op-ed published this month. “They create a more difficult path to recruit and retain students from racially and ethnically underrepresented backgrounds — despite the fact that we know diverse staff are needed to deliver the best care possible for an increasingly diverse U.S. population.” 

Pfizer was hit with a lawsuit from an anti-affirmative action group called Do No Harm in 2022 over allegations that one DEI-based fellowship program was discriminatory against white and Asian Americans. A court dismissed the lawsuit on the basis that it failed to identify anyone hurt by Pfizer’s program — a decision that was upheld in an appeals court earlier this year.

Otherwise, the pharma industry has largely been spared from the anti-DEI hoopla. And industry leaders, mindful of the tense political environment, have been making adjustments to keep it that way.

Ditching the word ‘diversity’

Several years into an industrywide push to ramp up the various strategies that fall under the “DEI” umbrella — including initiatives aimed at improving clinical trial diversity, corporate hiring and health equity —Big Pharma continues to shell out cash to keep the momentum going.

“Our commitment to DEI has not changed,” said Monique Adams, global head of diversity and inclusion in clinical trials at Sanofi.

The French pharma giant deepened its DEI efforts in October with a fresh $18 million commitment to support diversity in clinical trials through a 10-year investment plan for three historically Black colleges.

“[Sanofi’s] focus is around how we can ensure clinical trials represent the people with the diseases we are trying to treat,” Adams said. “These schools have access to communities that are people of color but also those of a lower socioeconomic status. They are already the messengers, and [we] wanted to help them build out their capabilities to become centers of excellence.”

Adams also noted that Sanofi’s investments aren’t meant to just tick a DEI strategy box but are based in the “scientific rationale” of ensuring its treatments work in various patient populations — a sentiment echoed by Xoli Belgrave, senior director and head of clinical trial diversity at the global CRO Parexel.

“Put aside social justice — diversity is just good science,” Belgrave said.

Parexel’s DEI strategies follow a familiar playbook in pharma. In the last few years, the company has worked closely with communities to drive clinical study awareness and recruitment. Parexel also weaves diversity goals into trial design and has positioned itself as a thought leader in the field by publishing research on socioeconomics. At this point, Belgrave noted, diversity goals have become more solidly baked into the clinical trials process with companies firmly behind the idea that it’s good for business. 

Still, there’s no escaping the fact that “diversity” is also politically loaded.

“Unfortunately, the word ‘diversity’ is so politicized,” Ribeiro said.

With the stakes so high, some companies are avoiding the word altogether. 

Walgreens, which has made patient inclusion and trial accessibility central tenets of its clinical trials business model, opts for the word “representation,” the company’s chief clinical trials officer, Ramita Tandon, said.

And even if pharma companies strengthen DEI strategies, Belgrave said there is a “possibility” the industry could ultimately shy away from the actual word.

Looking forward, Ribeiro said she’d like to see diversity, equity and inclusion goals pulled apart from the DEI acronym and repackaged to better reflect the complex strategies of improving clinical trial representation, boosting health equity and reforming hiring strategies.

“The default association with just race muddies the waters in terms of intentions,” she said. 

And because “a lot of what pharma is driving at is based on the FDA,” Ribeiro said, any industrywide shifts on DEI will likely depend on the agency’s stance.

The FDA issued new draft guidance on diversity in clinical trials earlier this year and is no longer taking feedback on the proposals. But with a new administration and leadership on the way to Washington, the regulatory future of DEI could be up in the air.

For industry leaders, the sooner DEI can lose its political baggage, the better.

“It’s distracting because you are focusing more on the language being used, and that takes away from the implementation of impactful work,” Ribeiro said.

The clinical trials industry is up against howling headwinds.

Novel therapies are more complicated to work with, staffing has been strained for years and the need to move efficiently and quickly without impacting quality is ceaseless.

Even positive developments can make work more complex. The regulatory push for DEI, for example, has the industry rethinking trial protocols and design. And new tech aimed at boosting efficiency brings the added challenge of training and preparing staff. 

On top of that, geopolitical issues in the Middle East and Russia’s war with Ukraine pose an ongoing threat to trials in those regions.  

“A lot of people assumed those [challenges] would stop, but they’ve gone on,” said Peyton Howell, CEO of global contract research organization Parexel, which runs trials in Israel and Ukraine. “It is concerning.”

Howell took the helm of Parexel in May and is eager to boast about its recent accomplishments, including DEI initiatives and industry awards. But Howell is also forthcoming about the challenges Parexel and other research organizations are up against. 

Tech’s promise and perils

The No. 1 question Parexel receives from pharma partners is about opportunities to use AI, Howell said.

“These tools might sound mundane, but they are the most exciting because they affect how a person spends time in their career,” Howell said, adding she’s particularly excited about tech “focused on study startup, patient recruitment and trial design. 

Still, the new platforms have to be tested and reviewed, and when they’re applied to operations, staff members have to be trained. AI platforms add another layer of tech to new demands already established by wearable devices for remote patient monitoring. 

In a study Parexel conducted with the Tufts Center for the Study of Drug Development, Howell said sites “expressed frustration with the number of different systems imposed on them and the complexity that tech burden creates.”

And those criticisms are being taken seriously, down to the letter.

“We are asking sites to do more. Some staff at sites say they feel like they’re in tech support right now,” Howell said, adding, “We’ve heard loud and clear from sites that we as an industry need to do a better job reducing the tech burden.”

The staffing crunch

The tech burden has also compounded ongoing staffing issues in clinical research. 

Although turnover has dropped significantly since the peak of the Great Resignation, and so far, the staffing crunch has yet to delay any trial starts at Parexel, recruiting new talent remains a challenge, Howell said. Research professionals for oncology, ophthalmology and neuroscience therapeutics are often in higher demand but have a smaller, more specialized talent pool.

 “The market remains competitive … meaning most new hires have more than one job offer,” Howell said.

To more quickly onboard and prepare research assistants, Parexel joined fellow CROs by launching a training program in 2022 for new hires. Called APEX, the program teaches the ins and outs of clinical work, such as navigating the required systems and patient monitoring. 

The Walgreens factor

Patient-guided trial design is a “biggie” in the industry, Howell said, but implementing it can be tough. And although many sponsors worry that gathering patient input will slow the trial process, Howell said it can speed the whole thing up. 

“Do it early and you’ll be more successful with recruitment and retention,” she said. “And it can reduce the cost burden because you are pressure testing the data you’ll need and the number of site visits you’ll need … which is a win-win.”

Going into the recruitment phase, Howell said patients need to remain at the center of protocol design to help retention.

“Clinical research has a burden on patients we need to understand,” Howell said.

Clinical research needs to meet patients where they are, Howell noted. 

“They want access to healthcare providers, but travel adds another burden,” she pointed out.

To bridge the access gap while improving diversity in clinical trials, pharmacy retail giants moved into the research arena — with mixed results.

Two years after launching a clinical trials division, CVS Health walked away in 2023.

CVS’ departure left more room in the market for Walgreens, which launched its clinical trials arm in 2022. Now, Walgreens said it’s reached 5 million patients to “potentially recruit into clinical trials.” 

Partnerships have also been key to the Walgreens strategy. Most recently, it struck a $100 million pact with the Biomedical Advanced Research and Development Authority to “increase innovation in decentralized clinical trials.” And earlier this year, Walgreens announced it’s teaming up with Boehringer Ingelheim to connect patients to phase 3 trials for the drugmaker’s GLP-1 candidate in obesity. 

Because of Walgreens’ capacity to recruit patients and provide trial sites, its foray into the space is a potential boon for research organizations like Parexel, Howell said.

“Seeing big companies like Walgreens in the arena is fantastic,” she said. 

Although Parexel doesn’t have an official partnership with Walgreens, Howell said the company is an “active supporter” of the pharmacy giant’s efforts.

Earlier this week, Walgreens announced it’s shuttering 1,200 pharmacies over the next three years in the wake of a $14 billion operating loss in fiscal year 2024. In an earnings report, the company didn’t indicate it plans to scale back the clinical trials business.  

Going forward with clinical trials, Howell said her advice to the pharmacy behemoth would be to “keep it simple.” 

“Focus on recruiting and bringing patients in,” she said. “I want patients to know about trials in a community setting, and I think that’s going to bring in a more diverse population — and that’s where we have strong alignment with Walgreens.”

When it comes to fomenting distrust in medical advances among people of color, the infamous Tuskegee experiments still play a major, disquieting role. Residual effects of the study that left hundreds of Black men untreated for syphilis without consent in the 1930s — and subsequent confirmed suspicions of scientific misconduct — carried through to the ongoing fight against HIV and into the COVID-19 pandemic in which so many more lost their lives.

While that distrust is deserved, it makes it more difficult for public health professionals to close disparities faced by minority populations in the U.S., said Dr. Reed Tuckson, a physician and founder of the Black Coalition Against Covid. He has also served as the commissioner of public health for Washington, D.C., in the 1980s and a vice president at UnitedHealth Group.

“It is frustrating to me that we have done nothing in 40 years to take Tuskegee off the table — that the No. 1 thing I would have to fight with HIV was Tuskegee, and the first question I was asked in my first town hall on COVID was Tuskegee,” Tuckson said. “It is a terrible indictment of America’s healthcare delivery, its health policy and its health promotion and prevention industries.”

A momentary success

In a recent paper written with James Mansi, Moderna’s vice president of North American medical affairs, Tuckson and colleagues reported that “uptake of the 2023/2024 COVID-19 vaccine was far from optimal,” falling particularly hard among U.S. minority groups. The decline followed a period of success when vaccination rates among Black Americans were reported in January 2022 to have risen sharply due to a large mobilization effort, closing the gap for a short time between the “two Americas,” Tuckson said.

That initial turnaround was a surprise to Tuckson and comprised one of the major lessons he took from the pandemic: reaching a community with factual, easily understandable health information can be accomplished. Still, a lack of consistency in messaging and required funding lies at the heart of health disparities in the U.S., he said.

“Black communities and health organizations are underfunded and only episodically funded for the disease of the week, crisis to crisis,” Tuckson said. “We jump from ice floe to ice floe without any sustainable infrastructure — there’s no garden, no oasis, you just see individual plants poking their heads through cracks in the concrete despite the sporadic funding year after year.”

The relative success of Black communities to rally around COVID vaccinations and preventive care came despite many hurdles, he said. Clinical trials with underrepresented minority cohorts, limited supply causing inequity in vaccine distribution and miscommunication among health professionals to communities of color all created challenges that leaders had to face.

“Success is relative,” Tuckson said. “We’re proud of the things we’ve done, but there’s such a long way to go and every day that trust is being eroded in every way possible.”

Calling on trusted messengers

From failures in the healthcare delivery system to misinformation and disinformation still rampant today in prevention circles, “that work [to build trust] is still very hard,” Tuckson said.

One lesson ingrained during the pandemic is that trusted messengers are key, he said. From pastors and ministers to fraternal organizations, as well as nurses, physicians and other health professionals of color, factual information from people in the community is crucial to sending the right message.

Dr. Kizzmekia Corbett, an immunologist who helped bring about COVID-19 vaccines through the NIH’s Vaccine Research Center, was an important role model and symbol for overcoming distrust, Tuckson said.

That’s where pharma can play a part, as well, he said.

“I would urge the pharma community to continue not only its hiring of the best scientists but to make sure they’re hiring excellent clinicians and scientists of color in responsible positions,” Tuckson said. “It’s important for the nation to know that we are in the room, not like the Tuskegee experience, but in decision-making power.”

Proactive, coordinated effort

The pharma industry has a notorious reputation problem, and not just among people of color. But rather than try to step back and let that reputation fall into the shadows, pharma companies — and other sectors in healthcare — need to step up and engender trust proactively, Tuckson said.

“Every single component of the health and medical care and policy system has its own challenges, and we cannot afford to have any sector decide to walk away or to be driven from the conversation,” Tuckson said. “Lord knows the history of misbehavior on the part of physicians, pharma, health insurance, you name it — every sector therefore has to be in the game and has to accept responsibility.”

The COVID pandemic illustrated that the disparate parts of the healthcare system can work together to handle a worldwide crisis, Tuckson said. Even with the missteps along the way, the cohesive effort has built momentum for the next health scares down the road.

“We’re in a better position because the resources at the community and national level are now more aware of one another, more coordinated,” Tuckson said. “The real issue now is to build on everything we’ve learned with the funding necessary for a sustainable infrastructure not only for the next pandemic, but for the high-priority epidemiological challenges that have always inflicted and plagued the Black community.”

Tuckson praised efforts undertaken by pharma companies to support higher vaccination rates among people of color, build trust through key messengers and make vaccines easier to find. Moderna and others, for example, have pushed for approval of a combination flu and COVID shot to improve vaccination rates. 

While the staggering loss of life in times of health crisis has shown the shortcomings of a health system not built with everyone in mind, Tuckson said, the efforts underway to close the gap make him optimistic.

“What is common to both COVID and HIV is the sub-optimal availability of an organized, engaged community infrastructure that has the strength and resources to fully exercise its capacity,” Tuckson said. “What is also common to both [HIV and COVID] is the extraordinary resolve and energy and determination by community and faith-based organizations in the minority community to fight for their own lives, and that was dramatically demonstrated in the COVID pandemic.”

Among the strategies Big Pharma is employing to achieve more equitable health outcomes, AI is now playing a larger role. For AstraZeneca, a series of AI-based partnerships and screening initiatives is setting the stage to gather and use data for cancer patients in neglected ZIP codes.

As it stands, innovation is outpacing health equity, widening the gap in oncology between patients who have access to novel medicines and those who do not, said AstraZeneca’s senior vice president and head of U.S. oncology Mohit Manrao.

Black Americans have higher death rates than any other racial group for many cancer types, according to the NIH’s National Cancer Institute. Furthermore, people without access to healthcare are more likely to be diagnosed later in their disease trajectory, putting them at greater risk of death.

“Science is moving so fast, but the job isn’t done after that,” Manrao said. “The challenge we have at a local level is that disparities are increasing, and more and more people fall through the cracks. Everyone in the system has good intent, but it’s important that as an industry, we embrace opportunities and collaborate to solve for it.”

AI is one of the most promising opportunities for improved health equity, Manrao said. By teaming up with diagnostic makers and AI companies, AstraZeneca wants to use data to expose the disparities in care, and address screening and access issues that exacerbate them. Manrao said AstraZeneca’s mission goes beyond developing oncology meds like the blockbuster Enhertu, which was originally approved for breast cancer in 2019 and recently scored a new expanded indication, and AI can find patients who need it.

“There is no reason that a Black woman with breast cancer in New York should have different outcomes than a white woman living in California or Atlanta — the ZIP code lottery exists today,” Manrao said.

Here, Manrao discusses the effect data-driven AI can have on the understanding and mitigating disparities in cancer care, the partnerships AstraZeneca has sought to bring AI into the fold, and how the feedback loop will also help drive better R&D for more equitable outcomes down the road.

This interview has been edited for brevity and style.

PHARMAVOICE: How do you characterize the impact that AI can have on patients, particularly from a health equity standpoint?

MOHIT MANRAO: Availability of data has multiplied in a multitude of ways, both in terms of genomic data and multi-omics data at a patient level and a customer engagement level.  Similarly, science, technology and data are converging very quickly, and that helps us believe we can have an impact on patients at every level. From a health equity lens, beyond our bread and butter in biopharmaceutical innovation, we want to start looking at the entire patient pathway and ask new questions. Are patients getting screened? What are the risk factors? Are they going to screening centers? Are they followed up appropriately in the system at the right intervals to be detected early?

Because of the socio-economic determinants of health, we need to have individualized interventions to solve for specific barriers that get in the way of a specific patient.

Because AI is trained using past examples, bias often finds its way into algorithms. How do you advance AI so that it can actually introduce progress rather than remain with the status quo?

It’s a super important point. Being aware of bias that would get into a system and putting checks and balances around it can help us look at health equity. Across the pharmaceutical value chain, it starts with inclusive R&D. We have drugs that get developed based on biosamples, and we’re working on creating diverse biosamples that are representative of the populations we serve. Of course, we can’t do that alone. So working at a local grassroots and community level to bring those diverse biosamples into drug development helps ensure that patient recruitment meets those goals. 

For instance, at a clinical trial centered in a community in New Jersey that is 18% Black, we work with them to ensure that not only 18% is recruited from that community, but more so that we can help dig and gather data. And all this serves to help AI predict without bias.

Your AI strategy has been heavily partner-focused. How does a potential partner stand out within the AI boom?

When ChatGPT came out, it exploded into the world in a visible way, but we have been using AI in different parts of the value chain already. We have more than 700 data scientists who are AI experts working in different parts of our organization from early drug discovery to development to commercial organizations and operations. We’ve embedded them to think in terms of looking for partnerships — we can’t move forward alone. So looking at the right partners with the capabilities, values and vision in terms of transforming cancer care is very critical. For example, in early detection, there are a multitude of challenges. If we see that tissue-based screening is a challenge, we work with blood-based companies to look at how we can help improve their assay. That led us to work with Grail in that space. 

Companies like Qure.ai can use technology to find lung nodules on X-rays that a naked eye couldn’t see, and companies like Clinithink have natural language processing that can go into electronic medical records. These are all important steps.

At the same time, let’s take the example of lung cancer — screening has been approved in the U.S. since 2013 and even a decade later, the uptake is dismal at only 5% to 6%. Socio-economic determinants are a barrier to lung cancer screening, and we’ve worked with the Association of Cancer Care Centers to understand and work with local communities, and use that rich data to inform where the pockets are, such as a rural Appalachian screening program for lung cancer in Kentucky. 

Similarly, we just announced a partnership with the University of Maryland system across counties in the state to identify at-risk populations. These academic and community institutes play a big part in the data-gathering process.

As you collect data, how does that feed back into the drug discovery and development process?

It’s critical that we put patients at the heart of drug discovery and development. All this data, in many ways, unlocks opportunities to uncover true unmet needs for patients, and the bigger picture is we want to eliminate cancer as a cause of death. Understanding through these datasets why the disease is progressing and informing R&D by identifying patients earlier. The partnership with Grail, for instance, helps us not only identify patients but also to look at the data and [see] which patients within this group are high-risk and the kinds of interventions they need. So this is integrated across the internal value chain.

The secret sauce for us, and it’s not truly secret, is external collaboration. We don’t shy away from partnering with the right party. What stands out for us and for anybody who wants to move the needle for patients is that we can’t work in silos.

The exclusion of women from clinical trials is rooted in historical tragedy. In the 1950s, when nearly 20,000 Americans took part in clinical trials for the drug thalidomide, including 600 pregnant women hoping to ease morning sickness, the study resulted in a massive wave of serious birth defects, including missing or deformed limbs.

The wide-scale shock helped prompt a 1977 FDA recommendation to exclude women of childbearing age from phase 1 and phase 2 trials, stalling a growing push at the time to bring more women into scientific research.

However, scientists found that excluding women from early-stage clinical trials came with its own set of consequences, including limiting the understanding of how women respond to various medications. So, in 1986 the NIH took the first in a series of steps to bring women back. 

Today, trial participation among women has increased, but they are often still underrepresented. 

A 2022 study found that women only made up, on average, 41% of more than a thousand reviewed trials — numbers that were often lower than the percentage of women affected by the diseases studied. In psychiatry, for example, women comprise 60% of patients but only 42% of trial participants. 

There is a renewed push to encourage more female participation and more studies geared toward women’s health. 

“Historically, conditions that primarily affect women have just not been researched at the same rate as indications that affect men,” said Cara Brant, CEO of Clinical Trial Media, a global recruitment and retention company. “And this is throughout the healthcare industry, both government and private.” 

But recently, progress is being made in research for diseases that primarily affect women, including breast cancer and endometriosis, Brant said. In March, President Joe Biden announced a new initiative to expand and improve women’s health research, which adds to ongoing efforts to diversify trial participation. 

“It's starting to feel like there's momentum around women's health research,” Brant said.

Encouraging participation

Enrolling women in clinical trials is crucial because women often react differently to drugs and have different presentations for many diseases, including cancer and cardiovascular diseases. 

“Our bodies are different. We process and metabolize medication differently,” Brant said. “Understanding that, I think, will help to improve drug effectiveness, safety and tolerability.” 

Women are also disproportionately affected by diseases such as Alzheimer’s disease and autoimmune disorders, and need better options for female-specific problems, such as menopause symptoms.

Women appear willing to sign up for trials. COVID helped raise awareness about the role and availability of clinical trials, Brant said. 

“It opened everybody's eyes to this industry that helps bring medications to market faster, and creates opportunities to see specialists and to get expert medical care in under-researched areas,” she said. “Interest is through the roof right now and I think women are just as interested as men, if not more.”

Although they may be eager to sign on, logistical barriers can block their path. Often they are the primary caregivers for children or aging parents in addition to work and may struggle to balance those responsibilities with that of a clinical trial commitment. 

“It’s almost impossible for moms to find time for themselves, much less the time that’s needed to participate in a clinical trial,” Brant said. “One thing that we hear consistently from women is that they have challenges with childcare and coming to appointments and just finding time for a scheduled visit.” 

Sites looking to increase women’s participation need to make changes to encourage participation, she said.

For one, they need to increase appointment flexibility, she said. Adjusting site hours to include later appointment times or weekend visits makes it easier for women to make the schedule work. 

“We have to look at how to be flexible and adapt to their lifestyle and their needs,” Brant said, pointing out that remote visit options offer another convenient option. “Maybe there's a telehealth visit or they can have their labs done [locally] as opposed to attending the site — it takes a lot of thoughtfulness and creativity, but I think that's what's needed at this moment.”

Trials should also make space for children, so women who can’t find childcare don’t have to cancel appointments or drop out. 

“I do think that when sites create a friendly environment for a woman who may have to attend an appointment with her child, it’s going to go a long way.” Brant said. This can be as simple as offering puzzles and games to keep children entertained in the waiting room. “Women love to know that their children are being thought of. That's a reflection on them and it makes them feel more relaxed, more comfortable. They don't have to feel on edge about bringing their child.”

Sites also need to open the lines of communication to get better results, Brant said.. 

“What we hear frequently from any participant is that for people [who] are new to clinical research there’s a lot of anxiety around what to expect: Where am I going? What happens at the study visit? How many visits are there? How long is it going to be?” Brant said. 

Providing guidance and information can ease uncertainty and make women more willing to participate. Asking participants for regular feedback to identify improvement targets can also help. For example, a survey might reveal that parking at the site is challenging, adding 20 to 30 minutes to the visit. 

“This person, who was showing up for a visit on time, is now going to be late to work,” she said. “That's a problem. It's such a small thing, but it's real.” 

Because trial participation can be taxing, sites should also let women know they appreciate the effort, acknowledging the sacrifice participants make. This might include a handwritten thank-you card or a small, inexpensive token of appreciation that shows you're thinking about them, Brant said. 

“I think women, like everybody, want to be heard, so give them an opportunity to have a voice and be included in the clinical trial process,” Brant said.