By Nick Davies, EY-Parthenon

How we address health disparities, especially regarding race and ethnicity, is critical to improving health outcomes for patients of all backgrounds. But the lack of diversity in clinical trials, due to shortcomings in the recruitment and retention of underrepresented patients, has been an issue. Clinical trial diversity is key to ensuring that approved medications are safe and effective for the intended treatment populations.

Executives of clinical trial sponsors and clinical research organizations (CROs) must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved 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 healthcare outcomes for all.

FDA Snapshot Of The Current Clinical Trial System

In the FDA’s Center for Drug Evaluation and Research’s (CDER) 2020 Drug Trials Snapshots Summary Report, 75% of participants in clinical trials for approved novel drugs were white, compared to other nationalities (11% Hispanic, 8% Black or African American, and 6% Asian). In response to this contrast, the FDA recently published updated guidance on enhancing the diversity of clinical trial populations and participation. Yet, there is no single solution to address the current lack of diversity among clinical trial participants, as shown by an EY-Parthenon survey of 176 patient respondents. Instead, executives should consider a series of connected, multifaceted solutions to address existing recruitment and retention shortcomings.

We believe that sponsors and CROs should explore a community-based approach to patient diversity in clinical trials. This would mean increasing patients’ general awareness and knowledge of the clinical trial process along with improving access to trials. Within both the biopharmaceutical (biopharma) and healthcare industries, as well as among lawmakers and regulators, there is more urgency around addressing the need for broader representation within clinical trials (this includes both the FDA guidance and bills in both the House and Senate).

Preclinical Trials

First, sponsors and stakeholders should actively listen to and directly engage with the patient populations that they seek to enroll in clinical trials. This is a critical step, especially given the longstanding mistrust among non-white communities related to medical research and healthcare, as well as a current misalignment between the specific needs of some patient communities and sponsor strategies. For example, our survey indicates that trial awareness programs and increased compensation are two of the top three ways to increase diversity in clinical trials, as noted by patients. Yet, there are minimal plans by companies to either initiate or continue either of these tactics. Engaging in two-way learning between industry and patients is key to increasing equity in clinical trials.

Further, according to our research, overall awareness and understanding of clinical trials, and how the process works, is low. This is particularly true for non-white survey respondents, who are almost twice as likely to be unaware of clinical trial opportunities. This demonstrates the need for stakeholders to improve outreach and educate communities on the clinical trial process.

As noted, there is a stark disconnect between sponsor-planned strategies and patient-indicated needs. Despite investments in educational and awareness programs in the last five years, no respondents who worked or currently work for clinical trial sponsors or at trial sites say their organization has plans to invest in those programs over the next three years.

Sponsors and CROs should invest in communication channels that are likely to reach historically underserved communities. Racial minorities who were surveyed indicated that they are much more likely to learn about clinical trials through social media platforms. They also reported that they heavily rely on other community members when making decisions about their personal health, as compared to their white counterparts. This finding may provide clinical trial stakeholders insight into how to improve their engagement with various patient populations.

Identifying credible influencers — faith-based leaders, business executives, community organizers — is key to gaining buy-in on the benefits of improving participation in clinical trials. These trusted leaders can then share information while answering questions from other community members.  Yale University’s Cultural Ambassadors Program and the University of Maryland’s School of Pharmacy PATIENTS Program are examples of programs that foster relationships with local communities and leverage community voices to support health education efforts and clinical trial recruitment.

During Clinical Trials

By understanding the key factors that both attract and repel potential clinical trial participants, one can enhance patient access — specifically those from underserved communities. Sometimes the answer is as simple as just asking patients to participate. According to our survey, 41% of non-white respondents reported that they have never even been asked to enroll in a clinical trial. Easy, actionable steps to encourage clinical trial participation can include directly asking patients to participate in clinical trials, addressing safety concerns, and continuing to alleviate any financial burdens of enrolling.

When asked what attracts patients to enroll in clinical trials, non-white respondents mention valuing the free medical care associated with trial participation, more so than their white counterparts (44% vs. 33%). Across all demographic groups, other attractive considerations are the potential of improving their own health, receiving compensation, and knowing that their participation can help improve patient outcomes.

Achieving increased clinical trial diversity will require investments not only in underserved communities, but also in clinical trial sites embedded in them. In a subset analysis of survey respondents with experience working in a hospital or healthcare system, additional barriers to diverse clinical trials were noted at the site level, and include understaffing, a lack of financial investment required to build the operational and technical infrastructure, and limited time available to dedicate to conducting quality clinical trials.

To combat these obstacles, sponsors and CROs may consider partnering with trusted institutions, such as pharmacies and urgent care clinics, to develop nontraditional clinical trial sites that are 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; and developing relationships and providing 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 may need adequate training and infrastructure to participate.

After A Clinical Trial

To create a lasting impact and sustain the diversifying of clinical trials, sponsors and other stakeholders will likely need ongoing engagement with select patient communities.  This continual investment, in the form of conducting community awareness and health education events, collecting post-trial feedback, and providing continuing education and training programs for investigators and site staff, can form the foundation of a lasting dialogue between communities and the industry.

Going forward, the biopharma and healthcare industries must collectively center their strategies and initiatives on communities and diversity, equity, and inclusion (DEI).

According to the EY-Parthenon survey, there may be a lack of prioritization and implementation of DEI programs throughout the industry – only about 54% of surveyed patients who also work for clinical trial sponsors indicate that they have programs in place specifically to address DEI.

Additionally, current programs focused on enhancing clinical trial diversity have not successfully addressed the targeted inequities. Less than half of non-white respondents believe that positive progress has been made toward establishing diverse clinical trials, and even fewer white respondents report positive progress.

Therefore, these findings suggest that the industry may need new strategies to make sustainable and impactful change. These community-centered tactics can include increasing knowledge and awareness, improving access to trials, and continuing industry engagement.

These initiatives have the potential to create a win-win-win scenario for patients, sponsors, and the healthcare ecosystem overall. It’s a win for patients and communities as they gain more equitable access to life-saving therapeutics. It’s a win for sponsors as they get a 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. Finally, it’s a win for the healthcare ecosystem overall because communities and patients develop meaningful, ongoing, and mutually beneficial relationships with healthcare providers, likely leading to sustained community engagement, increased patient access, and improved healthcare outcomes.

Continuous dialogue between patients and industry nurtures trust and offers communities the opportunity to take a more active role in clinical research. If successful, this trust can build a foundation for a sustained impact and improved patient outcomes across the healthcare spectrum.

About The Author:

Nick Davies is the EY-Parthenon R&D strategy leader. He has more than 25 years of experience working in and with pharmaceutical companies as a scientist, strategist, entrepreneur, and leader. He works extensively with healthcare and life sciences companies and private equity firms for both front-end strategic analyses and transaction-related advice. Davies’ strategy, consulting, and industry experience covers research and clinical development, compliance, quality, commercial and marketing, business development, M&A, external payer, access, and regulatory environments. He holds a Ph.D. in immunology and genetics from Cambridge University in England.

The views expressed by the authors are not necessarily those of Ernst & Young LLP or other members of the global EY organization