11 minute read 25 May 2022
Medical science laboratory scientists analyzing samples

How a community-based approach can improve clinical trial diversity

By Nick Davies, PhD

EY US Principal, EY-Parthenon Ernst & Young LLP R&D Strategy Leader

Scientist, strategist, entrepreneur, leader and C-suite advisor dedicated to accelerating the delivery of innovative medicines to patients. Husband, father, amateur musician and boat captain.

11 minute read 25 May 2022

Increasing clinical trial diversity can help improve health care outcomes. A community-based approach may boost participation in underserved populations.

In brief

  • Three-quarters of participants in trials for novel drugs are white, according to a 2020 FDA report.
  • An EY survey of patients shows a multifaceted, community-based approach may bring more minority participants into clinical trials.
  • The life sciences industry can learn from patients themselves about how to encourage more diverse groups to enroll in clinical trials.

Addressing health disparities, most notably with respect to race and ethnicity, is critical to improving health outcomes for patients of all backgrounds. One pervasive issue is the lack of diversity in the recruitment and retention of underrepresented patients in clinical trials. Clinical trial diversity helps ensure that the medications approved are effective and safe for the intended treatment populations. 

Change starts when the executives of clinical trial sponsors and clinical research organizations (CROs) collectively acknowledge that the system, as it currently stands, encourages several inequities that continue to lead to decreased access and poorer health care outcomes for diverse patient populations. By committing to a community-based approach to enhance clinical trial diversity, executives can increase the understanding of novel therapies and further enable improved health care outcomes for all.

FDA snapshot of the current clinical trial system 

In the FDA’s Center of Drug Evaluation and Research (CDER) 2020 Drug Trials Snapshots Summary Report, the average participation in clinical trials for approved novel drugs was over indexed with white participants (75%) and under indexed with non-white enrollees (i.e., 11% Hispanic, 8% Black or African American, and 6% Asian). In response, the FDA recently published updated guidance on enhancing the diversity of clinical trial populations and encouraged more diverse participation.

Meanwhile, an EY-Parthenon survey of 176 patient respondents shows there is no single solution to address the current lack of diversity among clinical trial participants. Instead, a series of connected, multifaceted solutions is needed to address existing recruitment and retention shortcomings. Therefore, prioritizing the most important levers that patients themselves point out can assist sponsors, CROs and other stakeholders with running more diverse clinical trials. These key considerations center on a community-based approach focused on increasing patients’ general knowledge and awareness of the clinical trial process, as well as which clinical trials are upcoming or in process, improving access to and the convenience of trials, and providing ongoing engagement.

Fortunately, there is growing momentum, both within the biopharmaceutical and health care industries, as well as among lawmakers and regulators, to address the growing need for diverse representation within clinical trials. This includes both the FDA guidance and bills in both the House and Senate.¹

Research firms, such as IQVIA, are further documenting the extent of this issue by reporting that after analyzing disease-specific epidemiology in 22 trials for US novel active substances (NASs) between 2019 and 2021, Black (78% of trials), Hispanic or Latino (45% of trials), and Asian (41% of trials) patients were underrepresented in many of the clinical trials. These trials included a variety of therapeutic areas that significantly affect a higher proportion of Black patients than their US demographic makeup of 13%, most notably, multiple sclerosis and multiple myeloma (21% and 26%, respectively).² Given this data and mounting pressure from regulators, industry sponsors and other clinical trial stakeholders need to consider a novel approach that will be both impactful as well as sustainable to address the current lack of racial and ethnic diversity in clinical trial participation.

Increasing diversity in the trial life cycle

Based on our patient survey, an effective approach to increasing diversity would be community based and integrating strategies that not only span the trial life cycle, but continue through ongoing engagement. (Figure 1).

  1. Pre-clinical trial: increasing patient knowledge by making specific efforts to educate and expand awareness of clinical trials in communities
  2. During clinical trial: enhancing participant access to and convenience of clinical trials by reducing barriers and supporting community-facing sites
  3. Post-clinical trial: maintaining community relationships through ongoing engagement and investment

Pre-clinical trial

Sponsors and stakeholders can begin by actively listening to and engaging directly with the diverse patient populations that they want to enroll in their clinical trials. This is critical given the well-founded, decades-long mistrust among diverse communities related to medical research and health care, as well as a current misalignment between sponsor strategies and the specific needs of diverse communities. These factors have led to the current situation related to patient enrollment in clinical trials. For example, our survey indicates that increased compensation and clinical trial awareness programs are two of the top three reasons perceived by patients as ways to increase diversity in clinical trials. Yet, survey participants who also either currently or recently worked for clinical trial sponsors indicate there are minimal plans by many companies to either initiate or continue the use of these strategies. Engaging in two-way learning between patients and industry is key to increasing equity in clinical trials.

Respondents indicate that their overall awareness that clinical trials exist, let alone their understanding of the clinical trial process, is low. This is particularly true for non-white survey respondents who are almost twice as likely to be unaware of clinical trial opportunities compared to their white counterparts (Figure 2). This represents a significant need for industry stakeholders to not only improve their outreach to diverse communities, but also educate them on the clinical trial process.

Figure 2

EY Figure 2_v2

As previously mentioned, there is an apparent disconnect between sponsor-planned strategies and patient-indicated needs. Despite investments in educational and awareness programs in the last five years, highlighted by survey respondents who worked or currently work for clinical trial sponsors or at trial sites and indicated investments in those programs, no respondents say their organization has plans to invest in those programs over the next three years (Figure 3).

Figure 3

EY Figure-3-v2

Given patient calls to increase clinical trial awareness broadly, sponsors and other clinical trial stakeholders may need to make sure they are investing in communication channels that are likely to reach and resonate with minority communities. Specifically, racial minorities in the survey indicate that they are much more likely to gain exposure to clinical trials through social media and more heavily rely on other community members compared to their white counterparts when making decisions about their personal health (Figure 4). This finding may provide insight for sponsors and other clinical trial stakeholders into how to refine and tailor their approach to engaging those from underrepresented communities. For example, they can cultivate relationships with trusted community members and collaborate with them to understand culturally relevant messages and approaches when communicating both in person and via social media platforms.

Developing trusted messenger programs relies on identifying credible members of communities — faith-based leaders, business leaders, community organizers — and gaining buy-in on the benefits of improving diverse participation in clinical trials. These trusted leaders can then share materials and information while answering questions other community members may have. Some notable examples of these programs include Yale University’s Cultural Ambassadors Program⁴ and the University of Maryland’s School of Pharmacy PATIENTS Program.⁵ Both institutions foster deep relationships with their diverse local communities and leverage the impact of community voices, such as faith-based leaders and other trusted community members to assist in clinical trial recruitment and health education efforts.

Figure 4

EY Figure-4-V2

During a clinical trial

Enhancing patient access begins by understanding the key factors that both attract and repel potential clinical trial participants — specifically those from underserved communities. Non-white survey respondents report multiple considerations are limiting their participation in clinical trials. Most notably, 41% of minority respondents report they have never even been asked to enroll in a clinical trial. Increasing the frequency in which minority patients are asked to participate in clinical trials, addressing the frequent safety concerns that diverse patients have regarding clinical trials and continuing to alleviate the financial burden of clinical trial participation are actionable steps to help limit factors that depress clinical trial participation among diverse patients (Figure 5). 

When asked to articulate the factors that attract them to enroll in clinical trials, more minority patients respond that they value the free medical care associated with trial participation than their white counterparts (44% vs. 33%) (Figure 5). Per the survey, the most attractive considerations across all races are the potential that the trial can help improve their own condition, receiving compensation for participation and knowing that their participation can help improve treatments for other patients.

Achieving increased clinical trial diversity will require investments not only in underserved communities at large, but also in clinical trial sites embedded in them. In a subset analysis of survey respondents with experience working in a hospital or health care system, additional barriers to diverse clinical trials were noted at the site level. Survey respondents who are also  involved in clinical trials report being unable to adequately staff their sites, a lack of financial investment required to build the operational and technical infrastructure, and limited time available to dedicate to conducting quality clinical trials as the most commonly perceived barriers. To combat these obstacles, biopharmaceutical industry stakeholders and sponsors may consider:

  • Developing relationships and providing the needed support for sites in underserved communities. Staff at these sites often have trusted relationships with their patients, along with a desire to conduct clinical trials, but need support in getting adequate training and infrastructure to participate. 
  • Partnering with trusted institutions, such as pharmacies and urgent care clinics, to develop nontraditional clinical trial sites that are often easier to access. 
  • Continuing to develop and invest in methods that ease the burden of travel, such as decentralized clinical trials and mobile nursing and lab units.

Figure 5

EY Figure-5-v2

After a clinical trial

Even with proper implementation of these strategies, to create a lasting impact and sustained recruitment of diverse patients into clinical trials, sponsors and other stakeholders may need to maintain ongoing engagement with diverse communities. This continual investment, in the form of collecting formalized post-trial feedback, conducting community awareness and health literacy events, and providing continuing education and training programs for investigators and site staff, will form the foundation of an ongoing dialogue between communities and the industry.

Making clinical trial diversity a reality

The biopharmaceutical and health care industries must collectively prioritize diversity, equity and inclusion (DEI) and center their strategies and initiatives on communities. Responses to the EY-Parthenon survey indicate there may be a lack of prioritization and implementation of DEI programs in the industry. While there has been broad recognition of the underrepresentation of minorities in clinical research, only about 54% of surveyed patients who also work for clinical trial sponsors (N=30) indicate that they have programs in place specifically to address DEI.

Further, the current approaches of the organizations that have programs focused on enhancing clinical trial diversity have not been viewed as successfully addressing the targeted inequities. Less than half of non-white survey respondents believe that positive progress has been made toward creating more diverse clinical trials, and even fewer white respondents report positive progress (Figure 6).

These results suggest that the industry may need to rely on novel strategies going forward to make sustainable and impactful change. These strategies include increasing knowledge and awareness, improving access to trials and continuing industry engagement — all through a community-centered approach.

Following through with these initiatives has the potential to create a win-win-win scenario for patients, the sponsors and the health care ecosystem overall.

  • Win for patients and communities: more equitable access to life saving therapeutics
  • Win for sponsors: collection of data that more accurately reflects the impact of their novel therapeutics programs on the intended treatment populations, while also preempting action by regulatory bodies
  • Win for the health care ecosystem overall: patients and communities develop meaningful, ongoing and mutually beneficial relationships with health care providers, likely leading to increased patient access, sustained community engagement and improved health care outcomes

Ongoing dialogue between patients and industry cultivates trust and offers communities the opportunity to take a more active role in clinical research. Ultimately, this trust can build a foundation for a sustained impact and improved patient outcomes.

Figure 6

EY Figure-6-V2

Kevin Anderson, Adam Berman, Rob Ghiano, Christina Kim and Caroline Smith contributed to this article.

Summary

Addressing health disparities is essential to improving health outcomes. But many communities are not represented in the clinical trials where treatments are tested and developed. A community-based approach can help improve clinical trial diversity.

About this article

By Nick Davies, PhD

EY US Principal, EY-Parthenon Ernst & Young LLP R&D Strategy Leader

Scientist, strategist, entrepreneur, leader and C-suite advisor dedicated to accelerating the delivery of innovative medicines to patients. Husband, father, amateur musician and boat captain.