Sites, sponsors, and other stakeholders often express interest in deepening connections with potential patient recruits from underrepresented groups. The American Kidney Fund (AKF)—a national nonprofit committed to promoting education, awareness, and research into kidney-related conditions—recently introduced a set of resources to help engage potential patients and inform them of the importance of trial participation.
Outsourcing-Pharma recently spoke with AKF president and CEO LaVarne Burton, who shared details about the newly introduced resources, as well as the importance of prioritizing special patient populations at every stage of a trial.
OSP: Could you please tell us a little bit about AKF—who you are, your mission, some of your awesome programs, and (specifically) how you work to advance kidney research/drug development?
LB: As the nation’s leading kidney nonprofit, the AKF fights kidney disease on all fronts. AKF works on behalf of the 37 million Americans living with kidney disease, as well as the millions more at risk. We have an unmatched scope of programs that address early detection, disease management across the full spectrum of kidney disease and rare kidney diseases, financial assistance, clinical trial awareness and participation, clinical research, innovation, and advocacy.
For three decades, we have supported clinical research, identifying emerging researchers seeking to advance care provided to kidney patients and providing fellowships to fund their research. AKF’s Clinical Scientist in Nephrology program has funded some of the field's most prominent researchers early in their careers, helping to address the shortage of nephrology researchers.
AKF also prioritizes supporting innovation in kidney treatments and working with industry to convey the value of the patient voice and participation across the research and development process. We work closely with pharma partners on a range of studies and leverage our reach to identify qualified and representative patients for trial recruitment.
AKF launched a campaign some years ago that encourages people of all backgrounds to participate in kidney-focused clinical trials to help ensure new therapies work for the people who need them the most. As part of that multi-year educational campaign, we recently launched new English and Spanish resources, including patient videos, a quiz, and downloadable guide to help patients decide about participating in a clinical trial. These resources can be viewed at kidneyfund.org/clinicaltrials.
AKF is also proud to be a member of the Digital Medicine Society’s (DiMe) Diversity, Equity, and Inclusion in Digitized Trials task force. In addition, our organization has commented on the FDA’s Spring 2022 draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the US into clinical trials. This guidance expands FDA’s previous guidance for industry to improve clinical trial diversity.
OSP: Please share some perspective about how kidney-related conditions impact various communities differently.
LB: People of all races and ethnicities are equally likely to develop kidney disease. However, Black, Hispanic American, Native American, and Asian American people are disproportionately affected by kidney failure, which is the final stage of chronic kidney disease. For example, Black Americans are 3.4 times more likely to develop kidney failure than white Americans. Also, Americans of Hispanic ethnicity are 1.5 times more likely to develop kidney failure compared to non-Hispanic Americans.
Multiple social and community factors exist that have contributed to this inequity, including systemic racial bias, access to timely preventative care, language barriers, and cultural differences. Higher risk among communities of color can also be partially attributed to greater rates of diabetes and high blood pressure in these communities. Diabetes and high blood pressure are the two greatest risk factors for kidney disease.
Recent research is also shedding light on genetic variants like APOL-1 that have been shown to be a significant risk factor for kidney failure among people of African descent (African American and Afro-Caribbean/Latino). Through AKF’s Health Equity Project and other dedicated initiatives, we are focused on reaching these at-risk audiences to educate, inform and empower them toward earlier and more accurate diagnoses and disease management. We also are working strategically through a coalition of professionals to communicate about the needs of these patient populations.
OSP: Then, how historically have trial teams done in terms of reaching, recruiting, and retaining patients from minority/underrepresented communities?
LB: Unfortunately, Black, Hispanic American, Native American, and Asian American people are often underrepresented in clinical trials, and these same groups are disproportionately affected by kidney failure. For example, about 33% of people with kidney failure are Black people, but only about one in 10 clinical trial participants are Black. Additionally, Hispanic people are nearly 1.5 times more likely to have kidney failure than non-Hispanics, but only one in 10 clinical trial participants are Hispanic.
Many complex barriers have contributed to a lack of diversity in clinical trials, including mistrust among certain communities based on historical abuses, racial bias among health care providers, language and cultural differences, and a lack of access to information about clinical trials and their safety measures. Clinical trial design and participant journey barriers also exist, such as lack of transportation or inability to go to appointments held during traditional work hours.
OSP: Please talk about why it’s crucial to connect with patients from communities of color.
LB: To ensure that new medicines and treatments work well for the people who need them, it’s crucial that clinical trials include people from diverse backgrounds, as well as individuals in rural geographic settings. Research has shown that people may have different reactions to treatments based on their race, ethnicity, gender, age, and other factors.
Therefore, it is important for clinical trials to include participants of different races, ethnicities, genders, ages, and lived experiences. That way, treatments for diseases like kidney disease will work for those who need them most.
OSP: Can you speak to some of the ways in which patients of color might weigh trial participation differently, and how trial teams can use that info to shape their recruitment/outreach efforts?
LB: It’s important for all parties involved in trial design and recruitment to understand the investment it takes to reach patient communities in the places where they are actively engaged, both on and offline. Successful partnerships in this space must take into consideration that patients face many challenges—physically, mentally, and financially—and we have a responsibility to support patients in a way that is sensitive to these challenges and makes life easier for them in any way possible.
Trial sponsors, contract research organizations, trial teams, and other stakeholders must be purposeful in bringing clinical trials to patients and work to enhance access to trials and minimize the burden associated with participation. We need to use technology and patient advocacy groups, like the American Kidney Fund, to help bring trials to patients where they are.
Trial sponsors should consider designing trials that include more decentralized practices. We need to focus on primary doctors, as well as doctors in rural settings and urgent care settings, to make them aware of available trials. In many cases, people of color would be willing to participate in a clinical trial if only it were recommended to them by their provider.
Other important considerations include making informational sessions and consent forms easier to understand and making trial participation accessible to patients who may not be able to take time off work or may not have easy access to transportation.
OSP: Then, how can organizations like yours contribute to the decision-making process by potential patients from communities of color?
LB: AKF leverages our connection and relationships within the community to drive awareness and engagement around clinical trials. We have a variety of ways to reach patients where they are, both on and offline. Through enhanced digital marketing tactics, we can deploy targeting options that enable us to attract the interest of qualified audiences and leverage the trust they have in AKF’s brand and in the information we share. Our messaging adheres to health literacy standards, and we consistently incorporate a broad representation of patients in our images and messages to reflect the diversity of our patient community.
In a research study at the outset of our work in clinical trial recruitment, we found that non-white participants were more likely to trust their friends or peers who have participated in clinical trials, so another important aspect of our work is trying to incorporate trusted voices into our campaigns. Once we’ve engaged key audiences, we drive them to educational resources about clinical trial participation, whether on a relevant clinical trial website or on AKF’s website, which reaches 19m people.
OSP: How might AKFs and similar groups help trials execute better trial design and outreach efforts?
LB: AKF and other patient advocacy organizations can play a key role in trial design and outreach efforts. Pharmaceutical companies and research teams looking to reach specific patient communities should engage advocacy groups as early as possible in the planning process.
In our experience, when we can be involved in clinical trial recruitment efforts from conception, we can share insightful input. For example, we can advise around the study design and how it will impact patients or provide feedback on the language being used to promote the trial to help ensure it adheres to health literacy standards. We can also help facilitate focus groups or panels to involve the patient voice throughout the process.
And finally, we can leverage AKF’s reputation, brand, and broad audience reach to help identify qualified and interested patients for trial recruitment. We always welcome inquiries about ways to partner together along our shared goals of improving patient outcomes.