Equitable Access to Healthcare and Clinical Research
The Importance of Grassroots Health Advocacy and Lay Navigation in Communities of Color
Karen Peterson
Karen’s Club

he impact of self-advocacy and the importance it plays in my life as a cancer survivor and patient advocate is significant. Diagnosed with Stage IV triple-negative breast cancer in 2017, I overcame an abundance of medical bias and lack of health literacy to save my life. With an original estimate of a 4% chance of survival, I am now one of the 12% of patients diagnosed with metastatic triple-negative breast cancer to make it to the five-year life expectancy benchmark.

After experiencing roadblocks including intentional bias and denial of access to critical biomarker testing, I divorced my original oncology team and ultimately found a researcher who valued my voice. Using the subsequent reports from the biomarker testing I received after switching medical teams, a collaborative decision was made to enroll me in a clinical research study. Incredibly, just eight weeks after starting the trial, my first CT scan revealed a 72% reduction in tumor lesions, and by 2019, I was declared a complete responder by my oncology and research teams.

I used this good fortune and a deep understanding of the patient “journey map” to co-found Karen’s Club, a small nonprofit organization that educates, informs, and supports cancer patients of color around clinical trials. Using my real-world experience as an intervention model, Karen’s Club provides free 1:1 consultation that provides opportunities for caregivers and patients to address concerns and needs when it comes to clinical trials, with the ultimate goal of empowering patients to make informed healthcare decisions.

We’ve made progress in addressing health inequalities but still have a long way to go. Redressing the dark past of neglectful medical care and experimentation within communities of color and overcoming fear and mistrust will take time. Reeducating healthcare providers and policy makers on what unbiased, equitable care looks like will take time. But cancer patients of color don’t have time; they need support now, and they need it from people who respect them, who know where they have been, and whom they can trust.

The Role of Lay Navigation and Intervention

Patient lay navigators play a vital role in guiding people through the healthcare system, helping people overcome barriers to get the information they need to make informed decisions about their care and access support. Lay navigator programs have been shown to improve care and experience for cancer patients and are becoming increasingly common, with the American Cancer Society noting them as critical to improving access to care for everyone. The impact of lay navigation on addressing disparities in clinical trial participation is less well documented.

After two years of engaging hundreds of patients and caregivers, Karen’s Club has observed some common themes:

  • Many people of color are not given the information to help them understand the value of clinical research and how it might help them. For the minority of people who do receive information, it is often communicated in complex scientific language that can be overwhelming and off-putting.
  • People also do not have access to the tools to support them to make informed decisions about clinical trial participation. Diagnostic tests and scans are important tools for understanding how effective treatments may be, so without access to them these people are missing out on opportunities that may be of real benefit.
  • Clinical research is rarely presented as a care option to people of color early in the treatment journey. The result is that people can miss the “window” for participation, only finding out about trials when their condition is too advanced for them to be able to participate.

Through a partnership with NYC’s Mount Sinai’s Tisch Cancer Institute, Karen’s Club is carrying out a pilot program to explore how lay navigation can help address some of these issues. The program will measure the impact of patient-centered Lay Navigation services in a phase 1 program. The project aims to determine:

  • The importance of health literacy in communities of color in relation to clinical research and how it affects their ability to make an informed decision.
  • What effect having a patient-led Lay Navigator of color has on the patient perception of clinical research and the importance, if any, of this role.
  • The point of entry of “the conversation”: When is it easiest and most meaningful to have the conversation about clinical trials?

This pilot program will also seek to measure the value to healthcare providers of patient-centered lay navigation services, and how these services could be made scalable throughout the healthcare industry. Making such grassroots programs sustainable and scalable is a vital part of addressing underrepresentation in clinical trials, which is becoming an increasing priority for regulators.

Collaboration: Transforming Plans into Action

In April 2022, US FDA issued a new draft guidance for industry which introduced Race and Ethnic Diversity Plans as an important part of a sponsor’s development program and recommended that such plans be submitted to the FDA early in the development process. At the end of 2022, President Biden signed into law the Food and Drug Omnibus Reform Act (FDORA) which established Diversity Plans as a requirement for all phase 3 drug and device studies.

Mandating diversity action plans is a significant and important step in advancing diversity in clinical trials in the US; however, it is vital that plans translate into meaningful actions. Collaboration with patients and communities is essential to achieving this. The American Cancer Society’s National Breast Cancer Roundtable Clinical Trial Working Group (NBCRT) is bringing together industry stakeholders and advocates to create best practices for equitable breast cancer care and is working on standardization proposals to be presented to the FDA in an effort to ensure accountability when it comes to implementing diversity plans across the industry.

Key Areas for Future Investment

Ensuring readiness within the industry is also vital, and efforts to promote increased education, knowledge, and awareness must be delivered across the healthcare ecosystem in partnership with community advocates. Key areas for future investment include:

  • Partnering with community-based organizations to advance health equity efforts, providing funding to explore and address barriers to clinical trial inclusion. For example, Gilead’s Toward Health Equity Oncology Grant is providing over $7 million in funding to community organizations to develop evidence-based interventions to improve equity in breast cancer care.
  • Building capacity for more clinical trials at nontraditional sites, such as community safety net hospitals, by investing in training and resourcing local communities to address barriers and enhance facilitators for trial enrollment.
  • Working with educational institutions to promote increased diversity within the science, research, and healthcare workforce. For example, the Beacon of Hope program is building alliances with Historically Black Colleges and Universities (HBCUs) to address systemic disparities in education and health outcomes.
  • Embedding cultural competency training into education across the clinical trial workforce, which has been shown to improve inclusion in trials.

As clinical research moves forward with new innovations and solutions, my hope is that the industry-wide diversity, equity, and inclusion awareness campaigns keep pace and ultimately lead to an increase in clinical trial participants from underserved communities of color. As for Karen’s Club, our goal is to continue to serve as a trusted and valuable resource, making a difference for patients.