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:
According to Deloitte’s report, Enhancing clinical trial diversity, biopharma 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.
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.
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.
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:
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:
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.
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.
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
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.
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.
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:
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:
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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