Operationalising diversity through site and patient engagement

Most sponsors are aware of the benefits that may arise from increasing the diversity of clinical trial patient populations. For example, closing gaps between clinical trial representation and real-world disease burden can help instil confidence in therapies and reduce the likelihood of unforeseen safety or efficacy concerns.

As with many aspects of clinical trial design, sponsors typically approach diversity, equity, and inclusion (DEI) efforts on a study-by-study basis. However, this makes replication and scalability difficult to achieve. In addition, DEI initiatives that start late in the clinical trial process may miss opportunities to make a meaningful impact and build trust within patient communities.

Therefore, sponsors may want to consider leveraging indication- or portfolio-level DEI strategies instead. By deploying DEI strategies across each stage of the development lifecycle, it’s possible to gain efficiencies and:

• better understand data needs related to underserved and underrepresented patient populations.
• proactively facilitate operational strategies that yield more meaningful inclusion of diverse populations.

In short, diversity may be better achieved through “operationalising” the engagement of underserved patient populations. The question then becomes: How?

Practical strategies to partner with sites

Engaging underrepresented patients may start with building trustworthy and sustainable relationships with community sites. Such relationships can be key for embedding indication- or portfolio-level clinical research into diverse communities because “operationalising” successful DEI activities requires sponsors, sites, patients, and community organisations to work together.

Because sites support and educate the communities they serve, their partnership may help facilitate patient engagement - and increase research awareness and access. However, it takes time to foster each unique site relationship. It is not something sponsors should expect to achieve quickly.

There is no standard, one-size-fits-all method for establishing your organisation as a trusted and durable community partner. Instead, sponsors can start by asking sites some simple questions:

• How can we support you and your patients in DEI partnership?
• How can we work together to meet the needs of the patients you serve?

Part of the subsequent conversation will undoubtedly centre on the financial, staffing, and time constraints under which most community sites operate, but that hinder study participation. For example, in the wake of provider burnout after the COVID-19 pandemic, few sites have enough staff or time to devote to clinical trials.

To address such constraints, sponsors can initiate discussions with sites to identify specific capacity-building, training, and clinical trial research infrastructure needs. Sponsors also may want to consider creating a full-time role within their organisations dedicated to engaging, training, and expanding capacity for community sites.

One sponsor company implemented a position it calls its Community Engagement Partner. The role’s responsibilities include introducing principal investigators (PIs) to the communities in which they conduct research. As a result of this outreach, PIs have met patients they otherwise wouldn’t have met, learned more about their real-world disease burdens, and better understood how their studies could help those patients.

Other strategies sponsors could leverage to deepen site relationships include:

• Engage sites in a portfolio review to identify multiple clinical development programmes that might be a good fit for the site’s patients. This allows sponsors to make upfront time, planning, and resource investments that can help create a mutually beneficial, long-term relationship.
• Offer cultural competency training for PIs and site staff.
• Develop a targeted strategy to elicit critical feedback from sites on DEI aimed at co-identifying needs, tools, and approaches to mitigate barriers to diverse study participation.

Practical strategies to engage patients

Although sustainable partnerships with community sites can increase visibility, rapport, and trust with diverse communities, sponsors can also directly engage diverse patient populations. For example, sponsors could fund support services (e.g., patient navigator, transportation, translation) that directly address patient-level barriers to clinical trial participation.

Many factors may limit diverse patients’ study participation, including lack of access to study sites, lack of awareness about clinical research, and lack of trust in clinical research. Yet, sponsors can collaborate with patients, patient advocacy groups, and sites to identify supportive services and options targeted to meet patients’ needs. For example, sponsors can help patients overcome:

• access challenges. Childcare/eldercare responsibilities, inflexible work schedules, and lack of transportation are all factors that can prevent diverse patient populations from accessing clinical trials. To address such challenges, sponsors can work with community sites to assess the possibility of offering more scheduling flexibility. Perhaps study visits could be conducted outside of regular clinic hours. Or sponsors and sites could explore decentralised study options, including telemedicine visits, remote data capture, and home health.
• awareness challenges. Many patients aren’t aware of clinical trials and don’t understand how investigational medical products are developed. So, sponsors can collaborate with sites to create easy-to-understand patient education materials. Once developed, sponsors can work with site staff to identify sustainable ways to integrate the information into routine patient visits.
• trust challenges. Lack of trust in clinical research exists at many levels, including among site staff and patients. Sponsors can begin to demonstrate their commitment to equity by acknowledging that historical and contemporary practices have generated a legitimate lack of trust within underserved communities. Then, sponsors can be active community participants, hosting engagement and educational activities that respond to the community's healthcare and clinical research interests. They can also develop trust by engaging diverse community members directly in clinical research activities at the site level.

Most importantly, diverse patient voices should be incorporated into trial design to ensure a pragmatic approach that includes patient optionality for how to participate. It is essential to listen to and truly partner with each patient community. Don’t presume that any idea is right for every site or patient population or individual patient.

Intentionality helps establish meaningful DEI

Increasing patient diversity in clinical trials does not happen overnight or with “drop-in” solutions. To create a meaningful and sustainable impact on DEI, sponsors should consider “operationalising” the engagement of underserved patient populations through indication- or portfolio-level DEI strategies. Building community trust and relationships takes time and intentionality. Still, sponsors that listen to, engage, and support community sites and their diverse patient populations can form durable and equitable partnerships that drive long-term benefits.