By Ed Miseta, Chief Editor, Clinical Leader
Patient recruitment, retention, and diversity in clinical trials has been an ongoing challenge. While there is an industry-wide effort underway to try and address these issues, they will not be truly impacted until researchers are able to create a better patient experience, do a better job of reaching patients from diverse communities, building true relationships, and working to co-create solutions as equal partners.
One company making a difference in this regard is Seagen Inc., a global biotechnology company developing and commercializing transformative cancer medicines. They credit their success to keeping a focus on patients and partnering with organizations on the front lines with diverse patient populations and in the clinical trial sites themselves. Seagen wanted to reach patients of diverse ethnic backgrounds and understand the barriers they face with clinical trials and find solutions for the patients and site partners.
To do this, Seagen engaged with the Tigerlily Foundation, whose mission is focused on providing education, awareness, and advocacy for breast cancer patients, specifically women of color. The organization’s vision is to end disparities of age, stage and color. Tigerlily has strategically focused on women of color, as Black women tend to have more aggressive cancers and a 40% higher mortality rate than their White counterparts. Maimah Karmo, Founder & CEO of Tigerlily Foundation, a female, Black-led patient organization on the forefront of driving change and patient-centric engagement when it comes to diversity in clinical trials, is herself a Black patient who experienced many of the disparities she has worked to eradicate. She saw that there was a lack of true collaboration between industry and patients and has worked as an integral part of Seagen to educate at all levels of the organization, addressing barriers and co-creating solutions. Also, she is able to be representative of the perspectives of the patients she supports.
“We all know there is a lack of education about trials in some communities,” says Karmo. “There is also mistrust of drug companies that need to be overcome. And, oftentimes, there is simply a lack of access to trials - or we have not been offered them. We have our finger on the pulse of what patients are feeling and experiencing through our Tiger Trials program. Our close, trusted relationships with communities of color have allowed us to share the barriers to trial participation we’ve identified and work with Seagen as they sought to ask what it could and should be done to overcome each challenge. Working with Seagen, we have also developed barrier toolkits that identify barriers, but more importantly offers resources and guides patients on how to self-advocate to overcome them. We will distribute these toolkits to patients, healthcare providers and hope to have kiosks in pharmacies and integrated into healthcare systems as well.”
Seagen also worked with Lazarex Foundation to get educated on barriers faced by patients, particularly surrounding the reimbursement of expenses incurred by patients who participate in clinical trials, including parking fees, travel-related costs and meals to name a few.
Reimbursement can be critical to getting patients enrolled in a trial, especially if those patients are lower income. Excessive costs can also lead to patient retention issues. The cost of missed work, gas, parking, tolls, and overnight stays can be too much for many families to absorb because it really adds up. Lazarex taught Seagen about what a huge issue reimbursement is for many patients so that they could find ways to better manage patient reimbursements and properly and clearly communicate in a culturally sensitive manner to patients and their families.
In speaking with site partners, Seagen then learned that managing patient reimbursements was often looked upon as an additional chore or burden by busy staff at the sites. For example, in partnership with Greenphire, Seagen evaluated other payment solutions by challenging them to look at what needed to be accomplished, how sites were being communicating with, how they were handling site and patient payments, and more. Together, they were able to do a deep dive on site activities and think about better ways of doing them.
The solutions put in place involved automating processes, reducing paperwork, and offering alternatives to patient checks, such as reloadable debit cards. Alternatives like debit cards can make patient payments easier for site staff but also help patients. Cashing a check can be difficult if a study participant doesn't have a checking account. Check cashing places will take a percentage of the check amount, reducing the proceeds to the patient.
Beyond identifying small solutions that make a big impact, the most important piece to ongoing, lasting change in clinical trial diversity and recruitment is open communication and trust within minority communities. It must stop being a transactional relationship and evolve into a long-term commitment – and not just for one trial but for all of them.