Case Study: Clinical Trial Diversity for Life-BTK

Neighborhoods with the highest amputation rates were redlined during segregation. So that's where we went to work.

Sustainability|Nov.02, 2021

We don't see clinical trial diversity as "nice to have." 

It’s a necessity.

One that our teams encounter every day. 

Take peripheral artery disease (PAD), a condition in which blood vessels — particularly in the legs — narrow or become blocked and can lead to amputation. PAD disproportionately impacts African American, Hispanic and Native American patients. Yet these communities remain drastically underrepresented in clinical research, making up less than 15% of participants in cardiovascular clinical trials from 2015 to 2019.

When we were planning the LIFE-BTK clinical trial to test an investigational device that treats blocked arteries in PAD, we had to ensure our research was representative of the populations that would most benefit from this treatment

We knew that …

  • Location of health services providers
  • Socioeconomic status
  • Language
  • Health literacy
  • Access to transportation to adequate healthcare services

... all have an impact on who ends up enrolled in clinical trials.

To reach communities most impacted by PAD, we couldn't fall back on old habits; seeking out clinical investigators who conducted research at hospitals and medical centers that have the infrastructure to run trials, but who didn’t necessarily have access to the patient populations most in need of a new treatment and with the least access to care.

We intentionally pursued investigators and sites that hadn't traditionally participated in clinical studies because we knew they had access to — and, more importantly, had earned the trust of — patient populations who would benefit most from this trial.

Jennifer Jones-McMeans PhD, the divisional vice president of global clinical affairs, is one of the people spearheading the change in clinical research.  She is the Abbott leader responsible for the LIFE-BTK trial and says, "If we went with the status quo and left the trial enrollment to the system itself, we would have ended up with a trial like every other trial before it, where racial and ethnic people are underrepresented and yet disproportionately affected by the disease."

We set out to find new ways to reach and recruit patients in these underserved communities. Our efforts have provided insights into how to address some of the major challenges people face when it comes to clinical trial participation, and we are working to carry this knowledge into other trials and share it with the industry through our recent white paper.

Challenge 1: Lack of Trust

  • The problem: Many people from communities of color mistrust the healthcare system and are particularly skeptical of clinical trials because of past injustices, including generations of not seeing themselves reflected in the medical establishment nor having access to optimal care. For example, Lyssa Ochoa, M.D., a board-certified vascular surgeon and clinical investigator for LIFE-BTK, serves communities in South San Antonio that have long experienced poor PAD outcomes. Dr. Ochoa believes the incidences of PAD can be traced back to the city’s history of segregation.

    "The neighborhoods here with the highest diabetic amputation rates were actually redlined neighborhoods back in the 1930s, where infrastructure into the communities was not accessible," she said.
  • How we are addressing it: Abbott is focusing on partnering with providers such as Dr. Ochoa — who has earned the trust of the communities she serves — to participate in LIFE-BTK as investigators. When she talks to her patients about the benefits of enrolling, it just means more because she has their confidence and carries that credibility.

    If physicians didn’t have experience participating in trials, we provide training, support and guidance on how to apply and enroll their patients.

    "We are reaching out to physicians who come from these communities, who themselves are part of the community," said Jones-McMeans, divisional vice president, global clinical affairs, Abbott. "We are providing the training, the mentoring and the resources they need to effectively participate in the trial."

Challenge 2: Lack of Understanding

  • The problem: Even when they hear about a trial from a trusted provider, many patients are unsure how a clinical trial works or how it benefits them and the larger community. Scientific jargon compounded by language barriers can also make it difficult for the average person to understand clinical trial materials.

    "When we choose to communicate only in English, we miss a whole segment of the population," Jones-McMeans said. "Something as simple as multilingual educational materials could open the possibility of increasing enrollment of patients whose mother tongue might be, for example, Spanish, Vietnamese or Hindi."
  • How we are addressing it: Abbott provides culturally appropriate, multilingual materials to LIFE-BTK investigators and sites to share with trial participants, including outlining benefits for them and the community at-large — especially in a trial for a disease that disproportionately affects their community.

    "Our goal is for patients to see themselves represented in the results," Jones-McMeans said. "Ultimately, their participation means that future patients will be able to hear from their doctor, 'This trial was conducted in populations just like yours and communities just like yours, so we are confident this is an effective way to treat your disease.' "

Challenge 3: Lack of Access

  • The problem: Many patients in underserved communities have difficulty getting to clinical trial sites or routine care follow-up appointments necessary to participate in a trial. The digital divide may also prevent them from being in frequent contact with the clinical trial team or participating in virtual follow-ups.

    "Most clinical trials occur in large academic centers, usually in urban areas," Ochoa said. "My patients don't have access to those areas of town. Many don't have the transportation or the means to provide the time and energy for all that goes into a clinical trial: the increased surveys, the pictures, the physical exams and so on."
  • How we are addressing it: We focused on partnering with sites such as the San Antonio Vascular and Endovascular Clinic, also known as the SAVE Clinic, that Ochoa opened in her community to serve patients with PAD. Many of these sites had never been involved in clinical trials, although they were hubs where patients in underserved neighborhoods sought care. As we did for the new clinical investigators, we are providing guidance and resources to help bring them into our trial network.

    "We made a conscious effort to select sites that not only have a diverse staff but also a diverse patient population and meet the needs of the underserved," Jones-McMeans said.

The Way Forward

Reducing practical barriers to participation requires solutions that will vary depending on the trial. They include:

  • Diversity experts: As a first step, we have created a Medical Advisory Board on Diversity composed of medical and population health experts — from physicians and researchers to academics and administrators — who are immersed in the clinical trial ecosystem and will provide guidance on designing future trials to be more inclusive.
  • Alleviating the financial burden: Those changes could include reducing the financial burden on patients by offering to reimburse patients for the cost of transportation to and from appointments, including ride-sharing services, or making follow-up visits less onerous by visiting patients at home or providing wearable or at-home monitoring devices to self-report their data.
  • Training and education on-site: We continue to expand our clinical trial networks by identifying new sites with more diverse staff and populations and provide them with ongoing mentoring and support. We have learned that sites lacking a research coordinator on staff can also be a major barrier, so we are designing grant programs to help sites hire and train for these roles and create a shared network of research coordinators across sites. In addition, working with contract research organizations (CRO) can be a way to reach a broader range of communities for multicenter clinical studies.
  • More than English: Developing informed consent materials in many languages and providing medical interpreters for patients whose first language is not English goes a long way toward making clinical trials more accessible to diverse communities. We are working to build these steps into the planning process for future trials across Abbott. 
  • Doctors within borders: To continue building trust among patients, we need to grow the pipeline of diverse medical leaders who live and work in the communities they serve. By creating scholarships for underrepresented medical students, including women and people of color, we can improve patients’ access to physicians who reflect the communities they serve. For example, we are contributing $5 million over the next five years to historically Black medical schools and nursing associations such as the National Black Nurses Association (NBNA) and the National Association of Hispanic Nurses (NAHN), to empower more diverse physicians and nurses to serve and represent their communities.

    The next step is to partner with medical schools and associations to connect these emerging providers and their communities to clinical trial opportunities. This includes providing training and mentoring for physicians who are new to being trial investigators or research coordinators, as we did in the LIFE-BTK trial. We plan to expand these learning opportunities to other physicians by hosting annual meetings to share knowledge, best practices and guidance to help them participate in more trials over time.
  • Doing the work, earning your trust: We are also continuing to research best practices to reach patient populations and build trust, enlisting the help of local community leaders as well as experts in health communications, behavioral economics and patient advocacy.

    We know there is a long way to go to improve diversity across the clinical trial ecosystem, but the LIFE-BTK trial shows that progress is possible when we go beyond our self-imposed boundaries and make the real effort to include physicians, sites and communities that have been historically left out and left behind.

    "We cannot simply give a passing consideration to diversity and inclusion in future clinical trials," Jennifer Jones-McMeans said. "We must continue to lead by example by using this experience as a model for inclusion of diverse and underserved populations."