Researchers Urged to ‘Meet Patients Where They Are’ to Build More Diverse Clinical Trials
Sponsors looking to increase diversity in clinical trials should, among other things, “meet patients where they are,” hire a more diverse pool of trial investigators, train nonminority investigators and deploy a patient-centric model for trials that includes input from Community Advisory Boards (CABs).
LaTasha Lee, vice president for social and clinical research and development for the National Minority Quality Forum (NMQF), said her ideal model for patient-centricity starts with a shared vision very early in the process.
“You build a culture of research and engagement within that community,” Lee said during a WCG Clinical webinar last week. “You find out the needs of that community — if their needs are educational materials, you co-create those. And then you begin to implement patient-centered approaches so that you can empower the community to make informed decisions about their care and treatment.”
Kathy Machuzak, director of patient advocacy in nephrology for Retrophin, said patients won’t come to investigators all the time. “You really need to meet them where they are — at church, in community centers, etc. — and have all of their messages be very culturally relevant,” she said. CABs that Retrophin has worked with previously “told us how we can find out more about what our patients are going through, what different organizations did in the past that they felt were successful to reach their communities and the different ways that we can collaborate with them.”
Machuzak added that Retrophin learned that it was essential to develop a strategic plan for increasing diversity at the beginning of the trials. “You have to bring in patients, caregivers, advocacy groups — they all are affected by the disease [being studied], but they all have specific information that they can provide to you.”
Lee cited the use of CABs in clinical trials for previous health scourges, including HIV/AIDS, cancer and cystic fibrosis.
“It brings diverse perspectives to conversations and lets you understand the needs of that community,” Lee said. “If you do this structure right, those CABs can actually inform your protocol, the design and the communications [of clinical trials] ... these are local individuals who are trained to understand clinical trials, who are your ‘boots on the ground.’”
To illustrate her point, Lee spoke about her previous work building a patient-centric clinical trial model for the ASH Research Collaborative Sickle Cell Disease Clinical Trials Network. After launching a comprehensive community engagement plan, Lee said a hub-and-spoke plan began to take shape, with a clinical trial unit or major academic medical center at its core. CABs, clinical research sites and a dedicated research coordinator became important cogs in the plan, which also called for leveraging real-world data and electronic health records in determining what eligibility criteria were being met at particular sites.
“We made a promise to the patient community that we were going to build a network with them and not simply for them,” Lee said. “This hub-and-spoke model helped to inform how we would design based on community input. They told us where they were and the [pediatric] centers they were seeing.”
Building trust in minority communities is essential. “It’s important for early and meaningful engagement of those populations, not just when you’re ready to launch a clinical trial, but as you are designing your clinical trials,” Lee said. “As part of that … engagement, you must begin with education and awareness — education of yourself, of that community’s needs and awareness of the challenges they face as individuals living with that disease, as well as education of the community in which you hope your product, device or area of study may inform. Letting them understand the clinical process is key.
“Because of the historical abuses in [minority] communities, often times there is a lot of misinformation and myths out there that must be tackled,” Lee said, adding that clinical trials should be designed around a wholistic approach to community-based involvement. “Patient centricity has been truly a revolutionary view. It is not only a requirement to include patient voices in all you do that is referenced by the FDA, but it’s important that you include the broader community — individuals living with a particular disease, their family members, caregivers and even those who advocate for them.”
Lee also called for increased diversity among clinical trial investigators but added if that wasn’t possible at a particular institution, “it is very important that you put your investigators through cultural competency training. And if companies are feeling that there are not enough diverse investigators in clinical trials, they should really employ strategies to support and train nonminority investigators on being connected to the communities in which they serve.”
Retrophin took that advice even further, according to Machuzak, by expanding the diversity of its patient advocacy team “and within other areas” of the San Diego-based biopharmaceutical. The company is also considering where their clinical trial sites should be located to ensure they are situated in areas near diverse patient populations.
“Work with your patient advocacy team,” Machuzak told attendees. “Your colleagues work with patient advocacy groups to help bring awareness in education about the clinical trials for that particular disease with the various groups. Listen to the patients. Find out as much as you can about their disease journey. Conduct advisory boards to get feedback on the patient journey — engagement initiatives that patient groups, hospital systems, religious and community centers, digital platforms or other programs — that may be available to reach the diverse patients for education about your clinical trial study.”
Machuzak advised researchers to discover other avenues and groups that they or their patient advocacy groups may not have collaborated with previously. She also urged them to engage with such groups to bring awareness in education about clinical studies.
“Develop trust with organizations that already have a relationship with the diverse patient community. Overall awareness about the need for diversity in clinical trials [can be achieved] by partnering with disease organizations and multicultural communities in ways that best engage with diverse patients.”
Both Retrophin and the NMQF have projects in the works. Lee said the latter would soon launch its Minority and Rural Coronavirus Insights Study (MRCIS), a five-year follow-up analysis of COVID-19 on communities of color that recently received IRB approval. She said MRCIS will be active in three states — Illinois, Louisiana and Ohio — with a goal of enrolling 5,000 patients. Negotiations are ongoing with two other undisclosed states. Samples from the study will be biobanked for future investigative work.
“In this model, we are leveraging the use of federally qualified health centers (FQHC),” Lee said. “This is key to ensure that these individuals who are often cared for by disproportionate health centers, hospitals, FQHCs, ACOs, etc. are being cared for.” She added that MRCIS is also tasked with “understanding the impact and perceptions of this disease, as well as understanding some of the disparities in care in various states related to this emerging pandemic.”
Meanwhile, Machuzak said Retrophin recently held an advisory board on engaging diverse patients with a rare kidney disease — specifically, African American patients with focal segmental glomerulosclerosis. “Our advisers included patient advocacy groups, nephrologists, the NMQF, multicultural consultants and groups that work with the African American community,” she said. “They provided many insights, such as the importance of understanding burden of disease; difficulties in getting off from work to go to screenings and testing; and the cost of travel to clinical trial sites, doctor appointments and access to specialists.”
Machuzak said Retrophin was also engaged in separate partnerships with Black Health Matters to develop awareness in education about rare kidney disease. The company also participated in a roundtable discussion recently on kidney disease with HHS officials and members of Congress. The discussion was hosted by NephCure Kidney International and Retrophin, in partnership with the American Association of Kidney Patients. A white paper summarizing the roundtable and final recommendations for novel therapies in rare nephrology is set to be released next month.