How Companies Tackle Diversity in Clinical Trials_hero

When it comes to clinical trial diversity, life sciences companies are taking steps to move the needle in the right direction. In this article, industry experts from Genentech, Moderna, and Patientory agree that collaboration is key to increasing diversity in clinical trials.


The lack of diversity in clinical trials isn’t a problem that will be solved overnight. But life sciences companies are taking steps to move the needle in the right direction.

Ubong Peters Ubong Peters

In the Citeline webinar, “Diversity in Clinical Trials: Data, Disclosure, and Due Diligence,” panelists talked about efforts their organizations are making to address diversity in clinical trials. Ubong Peters, lead clinical scientist at Genentech, a member of the Roche group, says his company has been tackling the problem of underrepresentation of historically underserved populations in clinical trials.

“Every year, Genentech provides a lot of support to communities that are working to advance inclusive research, to support communities that need some sort of financial funding to be able to provide services that would help create awareness within the communities about clinical trials and also bring those communities closer to our organization and our particular goals as a healthcare company,” he says.

“This year we had the Community Health Justice Fund,” he adds, referring to Genentech’s three-year, $6 million commitment to community-based organizations for improving the health of their communities.1

“The grants were provided by $6 million to various groups that are really working in the industry to try to make clinical trials more accessible to these underserved populations,” he says.

Apart from that, Peters says Genentech has dedicated roles within the organization to help advance inclusive research. “In my previous role, I was really deep down there in the trenches, mining clinical trial data from various sources, internal data sources, and also external data sources for valuable insights that we could then provide to study teams to advance inclusive research,” he says. “And there’s a whole team of folks that are doing this type of work.”

Peters currently represents Genentech as a clinical scientist on TransCelerate’s Diversity of Participants in Clinical Trials initiative. This initiative aims to tackle the problem of underrepresentation of racial and ethnic minorities in industry-sponsored clinical trials.

“[Genentech has] been engaging with other pharmaceutical companies as well,” he says, “like the work that I’m doing at TransCelerate, and we have collaborated with other experts at other pharmaceutical companies to really tackle these problems.”

Use Case: Meeting Diversity Goals Fast

Citeline worked with a late-stage biotechnology company that had specific diversity goals for the large Phase III trial of its next-generation COVID-19 vaccine. The company had an enrollment target of 30,000 volunteers with the following diversity parameters:

  • At least 25% being 65 or older
  • At least 15% being Black/African American
  • 10-25% being Latinx
  • 1-2% being American Indian

The company selected Citeline Connect to support the trial’s 30,000-participant goal. Using Citeline Connect, the sponsor was able to simultaneously work with many of the same recruiting partners that had already responded to its request for proposal (RFP), without the burden and risk associated with selecting just one.

Citeline Connect ultimately delivered 6,432 randomizations (22% of target) in a record 48 days, with over 50% being within the minority population.

Source: Citeline (2023) Clinical Trial Recruitment at Warp Speed [Accessed Oct. 31, 2023] "

Chrissa McFarlane Chrissa McFarlane

Chrissa McFarlane, founder and CEO of Patientory, founded the company in December 2015 after seeing the need in the market for more personalized and secure consumer-driven health information management solutions. She says one reason she started Patientory was because she saw there wasn’t a patient-centric approach to advancing diversity in clinical trials.

“The idea for Patientory actually came out of my experience in the telemedicine world and just the challenges when we look at data access and what that really means for improved health outcomes,” she says. “At Patientory, we really put patients back in the center of care by giving them a data wallet that they can [use to] securely aggregate all their medical and health information. And with this, we have the ability to really set a level playing field once people have their medical data and understand what that means for their health and how they can improve that overall.

“I really think that's the first step in also ensuring that we can have better representation when we talk about transparency, and that relies on having quality access to data and information. We feel … we’re at a crossroads in terms of technology advancements, as well as regulations here in the US with the 21st Century Cures Act, where we can start to progress towards this goal. And while I think we’re just at the starting point with this, it’s an ability for other organizations to really start to strategize and organize around information and really having that data to start to look at patient populations that need to be represented.”

A common language
Nader Daoud Nader Daoud

Nader Daoud, senior manager, clinical trial diversity & inclusion, patient and site experience (PASE) at Moderna, takes a data-driven approach to leading the equitable inclusion of people from all backgrounds in Moderna’s global clinical trials across various therapeutic areas.

Daoud says he believes advancing diversity in clinical trials starts with awareness. “It’s saying there is an issue. Clinical trial participation for people of color, particularly in the US, is historically at a misrepresentation, especially when you look at specific racial ethnic subgroups like Black African Americans, American Indian, Alaska, native, Hispanic or Latinx populations.”

Daoud says for Moderna it’s about acknowledging that misrepresentation and having a common language it shares with the industry and partners about what it means to be diverse. “Yes, there’s race and ethnicity, yes, there’s age, which is traditionally included in protocols. Yes, there is sex — again, traditionally included in protocols in some way,” he says. “But we don’t talk about other aspects. If you’re really talking about diversity, you have to think about systemic determinants of health. You have to think about sexual orientation and gender identity for sexually transmitted diseases, where it does matter. Not every disease, but there are indications where these sorts of social constructs do have correlations with people’s health. A lot, to us, about diversity starts with having this conversation, defining what we’re talking about and what it means to do well.”

The flip side of that, Daoud says, “is being able to measure that and communicate that to our sites, communicate that to our patients, and communicate that at large because it’s sort of difficult. And historically there’s this problem where you basically say diversity is good. I don't think anybody would disagree with that. But how do you define being good at diversity? Again, traditionally we use math. You have KPIs, you have metrics. So, we really think about doing that in order to be able to say, ‘Look, we are objectively doing better than where we were before.’”

Daoud says when it comes to tactical approaches, his organization’s mindset is about listening. “It’s about when you go to these groups that might have more information, either CRO networks or sites themselves or patient advisory groups, and you ask them questions, that you listen to the answers that they give you,” he says. “And I think that it’s really crucial — especially when we’re doing this work where there’s mistrust, where there’s distrust — to [respect the] time and [listen to] the feedback that different groups are giving you.

“And so, it starts with the participant, it’s about asking them for their feedback. Do you have some sort of process during the trial, during the work that’s being run to ask them, ‘How’s it going? What could we do better?’ Again, acknowledging that that’s different from an [adverse event] and that has to be clearly delineated, but more so what’s their experience, not just their satisfaction.”

Another thing Daoud says Moderna has does well is “developed a site advisory group which meets on a monthly basis with sites who are willing or interested in being involved with Moderna’s trials or are working on Moderna’s trials. They can give feedback as to what’s working on a protocol or what’s not working on a protocol in real time.

“Again, it offers a channel for listening,” he says. “And I think that that’s something that these conversations are important for and something that our industry can always use more of because of the fact that it’s incredibly complex. There’s nothing about this that works in a copy/paste setting from indication to indication, country to country, season to season. It’s individual work. We have to think about the individual and how we meet them where they are. And technology can do that if you use it well and intentionally, but it also means including a paper option at the end of the day, if someone doesn’t feel comfortable entering it on a phone or a computer. Paper is still technology.”

McFarlane says her company works in what they call the Web3 space, “ushering a new use of the internet where we’re democratizing not only data but access across the board.

“While people might not have access to healthcare, we know that the majority of the population has a smartphone, and this enables people to reach broader populations,” she says. “So, I would say technology [can be used] more as an enabler, as a support, as a democratizer to reach hard-to-reach populations that aren’t represented, who don’t have access to the best or quality healthcare services. We can really use technology to start to include these groups. And being able to use that from a smartphone, we get into the collection process — healthcare data, healthcare information, the ability to even connect wearable devices as we are entering into that age of consumer health and what that means.

“We’re all walking datasets, right? Whether we want to be included or not be included, we’re creating data on a daily basis. … And the ability to collect this information through technology is going to help us move further in not only investigations and studies, but also improving outcomes.”

Collaborating to diversify

Peters says he has noticed that once pharmaceutical companies are brought together to work under one roof, as in what’s being done at TransCelerate, “we’re no longer considered competitors, but all collaborating to try to resolve a common goal so that we can bring our new medicines to patients much faster.

“I think it’s the kind of system-level approach you need to tackle a serious problem like diversity in clinical trial participation because it's a very complicated problem, and there is no magic bullet that we can use here,” he says. “So, you just have to think about it from that system-level problem, and it needs a systemic solution as well.”

Peters says he would love to see more public-private partnerships where pharmaceutical companies are “able to go into the community, bring everyone who needs to be at the table to sit together and to tackle this issue.

“One great example that we’ve seen come out was with Bristol Myers Squibb launching that diversity in clinical trials development program and entering into a partnership with the National Medical Foundation and investing over $100 million into that program,” he says. “And Genentech also had its own version of that same kind of strategy where we were committing nearly $200 million since 2017 to try to fund this health equity and diversity in STEM innovation fund…. It would be great to see more of those kinds of private-public partnerships between both governments and the industry to try to tackle this issue.”

“I think [working toward diversity] comes from a collaborative approach,” McFarlane says. “It comes from multiple resources coming together from technology enablement and breaking down silos and access to data and organizations coming in and collaboratively working together to improve health outcomes. So, I think once we start to really change that mindset into more of a collaborative one, we can just continue to move towards those improved goals with those small steps.”

A Few Company Metrics on Clinical Trial Diversity

Most pharma and biotech companies have a stated commitment to diversity and inclusion in clinical trials. But some are tracking the numbers more closely than others. Here is a sampling of company metrics:

Bristol Myers Squibb

  • In 2021, 54% of Bristol Myers Squibb’s US clinical trial sites were located in highly diverse communities.2

Eli Lilly

  • In June 2022, Lilly noted that among the most recent 12,000 patients it enrolled in clinical trials, 39% were minorities. Of those patients, 18% were Hispanic and 11.5% were African American, compared with 18% and 13% in the US population, respectively.3

GSK

  • GSK announced its intention to include a demographics plan in at least 75% of its Phase III trials in 2022.4

Merck & Co.

  • In 2022, about 50% of Merck’s clinical trial participants worldwide were from historically underrepresented groups.5

Pfizer

  • In 2019, 64% of Pfizer’s Phase II and Phase III study starts were tracking diversity. The company also has 49 clinical sites committed to tracking diversity.6
  • In 2020, Pfizer and BioNTech incorporated diversity in their Phase III clinical trial for the SARS-CoV-2 vaccine BNT162b2. About 42% of global participants and 30% of US participants in the trial were of diverse racial and ethnic backgrounds.7

 

1 Genentech (2023) Community Health Justice Fund. Available from https://www.gene.com/stories/community-health-justice-fund [Accessed Oct. 31, 2023].

2 Bristol Myers Squibb (2022) 2021 Global Inclusion & Diversity Report. Available from https://www.bms.com/assets/bms/us/en-us/pdf/2021-bms-global-diversity-inclusion-report.pdf [Accessed Oct. 13, 2023].

3 Eli Lilly and Company (2022) Researching Medicines in a Diverse World. Available from https://www.esg.lilly.com/stories/increasing-diversity-clinical-trials [Accessed Oct. 13, 2023].

4 GSK (2001-2023) Diversity, equity and inclusion. Available from https://us.gsk.com/en-us/responsibility/diversity-equity-and-inclusion/ [Accessed Oct. 13, 2023].

5 Merck (2023) Diversity in clinical trials. Available from https://www.merck.com/research/diversity-in-clinical-trials/ [Accessed Oct. 13, 2023].

6 Pfizer (2019) Pfizer 2019 Annual Review. Available from https://www.pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2019/our-bold-moves/unleash-the-power-of-our-people/building-a-more-diverse-pfizer/index.html [Accessed Oct. 13, 2023].

7 Pfizer (2020) Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. Available from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine [Accessed Oct. 13, 2023].

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