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Broadening clinical trial participation to improve health equity

Community-based organizations can help reach a broader population and enhance clinical trial diversity. Discover how to meet consumers where they are.

Historically, the consumers who participate in clinical trials haven’t reflected the diverse fabric of the United States or represented the patients who would benefit the most from the interventions being studied. While diversity has become a priority in clinical research, racially and ethnically diverse populations—and other underrepresented populations—typically continue to be left out.1

Are all consumers equally aware of what a clinical trial is and what opportunities there are to participate? Which community entities do consumers trust and seek information from? How does convenience influence consumers’ willingness to participate in a clinical trial? These are just a few of the questions that the industry continues to grapple with. By asking consumers what they think, we can gain a better understanding of the challenges to diversifying clinical trials—and what can be done to address them.

Biopharma companies and industry stakeholders, including academia, government, health systems, and patient advocacy groups, have made significant investments to address access, awareness, and trust issues that can limit racial and ethnic diversity in clinical trials (see sidebar, “The importance of racial and ethnic diversity in clinical trials,” for more information).2 Regulatory authorities are also committed to enhancing racial and ethnic diversity in study designs and drug applications. In alignment with their Diversity in Clinical Trials Initiative,3 the FDA announced new guidance aimed at increasing racial and ethnic diversity in clinical trials for all medical products.4 While the industry is pursuing various strategies to overcome these barriers, there is consensus on the need to meet patients where they live and where they already interact with trusted health care providers in the community.

While these efforts have shown early success in enhancing diverse participation in clinical trials, little research has been conducted on what consumers have to say about these strategies more broadly and the impact they would have to increase diverse participation in clinical trials. To understand consumer sentiments around community-based solutions and their impact on clinical trial participation—and to help biopharma companies and industry stakeholders tailor their efforts—the Deloitte Center for Health Solutions surveyed 4,545 US adult health care consumers between February 24 and March 14, 2022. We found that:

  • There are more opportunities to enhance consumer awareness:
    • Asian, Black, and Hispanic respondents were nearly twice as likely as white respondents to have never heard of a clinical trial.
    • Community-based organizations are the most trusted entities to share health care information and to improve the patient experience. And because they are places where consumers are already seeking health care services, they may be best positioned to educate patients on clinical trials.
  • More work needs to be done to reduce the burden of clinical trial participation:
    • Only 35% of all consumers are willing to participate in a clinical trial at a traditional research centre.
    • Offering clinical trials from home or virtually would increase consumers’ willingness to participate in a clinical trial by nearly 20 percentage points and offering clinical trials at a convenient site would increase willingness by nearly 10 percentage points. This is particularly evident among certain ethnic groups:
      • Asian respondents are 20% more willing to participate in clinical trials if offered virtually.
      • Asian respondents are 16% more willing to participate in a clinical trial if offered at a local retail clinic, and Black and Hispanic respondents are nearly 9% more willing, compared to only 6% among white respondents.

According to Deloitte’s report, Enhancing clinical trial diversitybiopharma companies are leveraging digital solutions and partnering with community-based sites to foster awareness and reduce patient burden. For example, biopharma companies are adapting protocol design to enable decentralized and remote trials, and partnering with trusted community-based organizations, such as retail clinics and community health centres. Unlike the large medical facilities where many clinical trials take place, community-based sites are conveniently located within neighborhoods and consumers already visit them.

Cross-stakeholder commitment and collaboration is needed to enhance diversity in clinical trials. Community-based organizations can be used to overcome barriers to participation while increasing awareness and building trust—but no single organization can do this alone.

The importance of racial and ethnic diversity in clinical trials

Clinical trials test the safety and efficacy of medicines and vaccines and provide patients with access to potentially life-saving therapies that otherwise might not be available. However, clinical trial participant pools often don’t reflect the racial and ethnic diversity of the US population. While racially and ethnically diverse consumers make up nearly 40% of the population, about 80% of clinical trial participants are white.5

Additionally, clinical trial participants don’t represent the populations that use the medicines and vaccines being evaluated. In fact, less than 20% of approved drugs have data that evaluated the treatment benefits or side effects on Black patients, according to a recent study.6 Distrust of the medical community, limited access to trial sites, and a general lack of awareness about clinical trials are among the barriers that keep many people from participating.7 Improving access to clinical trial diversity can improve health equity as well as the scientific rigor of studies.

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Improve clinical trial diversity with better consumer awareness

Patient awareness and education around clinical trial research, including the purpose of the research and the role they play as participants, is often seen as the first step in enhancing diverse participation in research, according to the National Institutes of Health.8 Yet many consumers lack general awareness of clinical trials. This is particularly evident among racially and ethnically diverse consumers. According to our survey, Asian, Black, and Hispanic consumers were nearly twice as likely as white consumers to have never heard of a clinical trial (figure 1).

Even when accounting for other factors, like education and income, awareness of clinical trials was much lower among racially and ethnically diverse consumers than among white consumers. According to a recent Deloitte report, Enhancing clinical trial diversity, limited information about clinical trials, and not being asked to participate, were the top barriers to participation.

Engaging trusted community resources to boost clinical trial awareness

The ability to provide education about clinical trials in the local community is important and trusted messengers are essential. Community-based organizations like retail clinics, pharmacies, and community health centres are often staffed by clinicians like nurse practitioners and physician assistants, and some are co-located with pharmacies. Each of these entities are trusted sources for health care information and serve as partners for improving the patient experience more broadly. Our survey found:

  • Consumers trust their clinicians (70%) and pharmacists (47%) to provide treatment information, and trust their clinicians (67%) and pharmacists (47%) to provide public health information.
  • Consumers also are going to their clinicians for health care information at higher rates. In the past year, 50% of all respondents went to their doctor for public health information, an increase from 42% in 2021.
  • Pharmacies, community health centres and grocery stores were ranked as the most trusted organizations consumers want to see their hospital partner with to improve patient experience more broadly.

Community-based organizations are also places where consumers already go or would go on a regular basis for health care. For example, consumers often visit a pharmacy to pick up prescription medications. Our recent article, Advancing health through alternative sites of care, highlights how consumers are increasingly willing to seek health care from community-based sites:

  • On average, 55% of all consumers are “likely to” or “maybe would” use a retail clinic for preventative care. This increases to 66% among Asian consumers, 59% among Black consumers, and 63% among Hispanic consumers.
  • On average, 60% of all consumers are “likely to” or “maybe would” use a community clinic or health centre for preventative care. This increases to 70% among Black consumers, 66% among Asian consumers, and 69% among Hispanic consumers.

Community-based sites can also provide an opportunity to connect consumers with care teams that are diverse and with clinicians that have shared life experiences,9 which can improve and rebuild trust. According to our report, Rebuilding trust in health care, half of all consumers are willing to trade access to convenient care for access to a provider who looks similar to them or has shared life experiences. Deloitte’s report, Advancing health equity through community-based ecosystems, provides insight into building and sustaining these community partnerships to advance health equity.

Reducing the burden of clinical trial participation

In addition to awareness and trust, access to clinical trials remains a top challenge.10 Participation in clinical trials often requires patients to make regular visits to traditional clinical trial sites, which tend to be in hospitals or other large medical institutions. For many patients, these facilities aren’t conveniently located. In fact, about 70% of potential participants live more than two hours from the nearest study centre.11 Participating in a trial often requires consumers to have reliable transportation, take time off from work, and find childcare.12 According to our survey findings, 35% of all consumers would be “extremely” or “very willing” to participate in a clinical trial at a traditional research centre. However, offering decentralized trials and conveniently located community-based clinical trials at trusted locations, significantly increases consumers’ willingness to participate.

Allowing patients to participate from home

Decentralized clinical trials (DCT), which leverage video visits, inhome testing, and remote monitoring and diagnostics, can help address barriers to participation by limiting the need for onsite visits. DCTs reduced the clinical trial timeline and yielded a return on investment five times the original investment in phase II deployments; and 14 times the investment for phase III deployment, according to a Tufts Center for the Study of Drug Development study.13

According to our survey, consumers are 17% more willing to participate in a clinical trial if it were offered at home compared to a research centre, with 52% of all consumers saying they would be “extremely willing” or “very willing” to participate. Additionally, consumers are 15% more willing to participate in a clinical trial if it were offered virtually compared to a research centre, with 50% of all consumers saying they would be “extremely willing” or “very willing” to participate (figure 2). This is particularly evident among Asian consumers, with Asian consumers 20% more likely to say they would be “extremely willing” or “very willing” to participate in a clinical trial if offered virtually.

In spring 2020, we predicted that the COVID-19 pandemic likely would expedite the transition to remote or virtual trials from years to a few months. This prediction came to fruition, with new research showing that DCTs grew three-fold with 87% of CROs using or planning to conduct clinical trials digitally, compared with 28% before the pandemic.14 Data suggests15 this trend will continue and prove beneficial for enhancing diversity in certain clinical trials that have been traditionally hard to recruit for, like rare diseases, as well as increase enrollment for cancer patients.16

Using digital tools to enable decentralized trials

Consumers are increasingly using smartphones, video applications, and other digital tools to engage with their health care provider virtually, measure fitness levels, and improve their health. In 2022, we found that 49% of all consumers used devices to measure fitness or improve health, up from 28% in 2015.17 According to our article, Tapping virtual health’s full potential, 42% of consumers used a virtual visit for their health care needs, compared with only 17% in 2018. These devices and digital tools can be used to support DCTs by enabling remote patient monitoring and data collection.18 As consumers own and become more comfortable using these devices and digital tools, biopharma companies should continue to assess protocol designs and digital tools to explore which trials could be decentralized.

Using technology to enhance participation among Medicaid beneficiaries

Adult Medicaid beneficiaries tend to have low incomes and education levels and are more likely to have social needs related to housing, employment, and food insecurity.19 Due to these social needs, Medicaid beneficiaries often are unable to participate in clinical trials. However, remote trials may provide an opportunity to enhance enrollment for Medicaid beneficiaries. Our survey found that adult Medicaid beneficiaries own smartphones (97%) at nearly the same rate as the general adult US population (96%). Additionally, more Medicaid beneficiaries own wearables: Since 2018, there has been an increase of 5 percentage points in the number of Medicaid consumers who own a wearable with 34% of all Medicaid consumers saying they own a wearable in 2022. Using digital tools to enhance the enrollment of Medicaid beneficiaries goes beyond creating equitable access to clinical trials. Since most Medicaid beneficiaries are racially and ethnically diverse,20 enrolling more Medicaid beneficiaries in clinical trials can in turn increase diverse participation in clinical trials more broadly.

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Offering convenient clinical trial sites

In addition to being trusted and convenient resources for health care information, retail clinics and other community sites like schools and religious organizations, are being explored as convenient and accessible clinical trial sites. We found that consumers are more willing to participate in a clinical trial if it’s offered at one of these sites rather than a traditional research centre:

  • Retail clinicsRetail clinics often are conveniently located and can be found in more than 3,000 pharmacies, grocery stores, and big-box retail stores across the US.21 Retail pharmacies have already begun to incorporate health care into their business solutions, including pursuing opportunities in clinical trial recruitment and retention.22According to our survey, offering clinical trials at retail clinics increases consumers’ willingness to participate by 8 percentage points, with 43% of all consumers saying they would be very or extremely willing to participate. This is particularly evident among racially and ethnically diverse consumers (figure 3). Offering clinical trials at retail clinics increases consumers’ willingness to participate by 16 percentage points for Asian consumers, 9 percentage points for Hispanic consumers, and 8 percentage points for Black consumers.
  • Other community-based sites: Nearly 50% of surveyed consumers are very or extremely willing to participate in clinical trials offered at neighborhood locations (figure 4). The industry has already begun identifying and engaging community-based sites to reduce participation burden. Last year, Mayo Clinic and several health organizations launched Advancing Clinical Trials at the Point of Care Coalition, an initiative aimed at partnering with community-based care organizations, to enhance clinical trial capacity and effectiveness including enrolling diverse trial participants.23

Activating the community to encourage diverse participation

The COVID-19 pandemic shaped a new era in clinical trials, with many pharmaceutical companies exploring ways to meet consumers where they are and interact with trusted community-based organizations. This includes exploring home-based clinical trials through digital technologies like wearable devices and remote patient monitoring tools,24 and pursuing partnerships with community-based organizations that foster patient engagement.

Community-based solutions can be used to overcome participation barriers while increasing awareness and building trust—but no single organization can do this alone. It will likely require long-term cross-industry collaboration and investment through partnerships with technology vendors, community-based organizations, and other stakeholders, particularly focusing their efforts in the following areas:

  • Enhance efforts to increase awareness: According to our vision for the Future of HealthTM, consumers are taking ownership of their own health—and will continue to do so. Increasing clinician and consumer awareness of clinical trials can help make this a reality by giving consumers more information that is applicable to their health and wellness, including opportunities to participate in a clinical trial. This may require a grassroots approach to connect with individual health care providers and community leaders and/or a broad, national awareness campaign to reach consumers. Awareness is an essential first step. Without it, we can’t build trust and expand access.
  • Partner and invest in the community: Community relationships can be critical to enhancing diverse participation in clinical trials. This requires building and sustaining relationships over time, and a long-term commitment rooted in a shared agenda of improving health equity within communities. Pharmaceutical companies should invest in the infrastructure needed to set up clinical trials at community-based sites as well as in the community to provide education, monetary investments, and support to address barriers to health equity more broadly.
  • Assess digital tools for decentralized and hybrid trialsCompanies should assess their protocols to explore which clinical trials could be conducted virtually or via a hybrid arrangement instead of the traditional in-person format. This might include evaluating technologies for virtual health visits, assessing connected digital and mobile health tools for remote patient monitoring and data collection, and incorporating new data sets and workflow changes into the broader clinical trial process. During this assessment, it is critical to consider data privacy and security concerns as well as global regulations and the cultural nuances of remote visits.

Our research provides evidence that many consumers are willing to participate in clinical trials when they’re aware of the opportunities and when they’re offered at convenient, trusted locations like pharmacies, retail clinics, and community health centres. Consumers are also increasingly using and becoming familiar with digital tools like smartphones, wearables, and virtual health platforms. Consumers’ increased willingness on both fronts may make it easier for biopharma companies to decentralise clinical trials while also exploring other digital solutions. Biopharma companies should partner with trusted entities and explore digital solutions to bridge the gap between health care and clinical research to ultimately enhance diverse participation in clinical trials and improve health equity.

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Project team: Leslie Korenda led the survey development and provided guidance throughout the project. Apoorva Singh contributed significantly to the research and analysis of the findings. Wendy Gerhardt provided project management support and guidance.

The authors would also like to thank Tom Yang and Laura Kelly for their insights and feedback. The authors would also like to thank Rebecca Knutsen, Laura DeSimio, Zion Bereket, Natasha Elsner, Leena Gupta, Steve Davis, and the many others who contributed to the success of this project.

The study would not have been possible without our research participants who graciously agreed to participate in the survey. They were generous with their time and insights. 

Cover image by: Natalie Pfaff.

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