How — And Why — To Embrace Intersectionality In Clinical Trials

By Inez Ruiz-White, Ph.D., Otsuka Pharmaceutical Development & Commercialization, Inc.

Patients are people first, and healthcare must be delivered as human care. To deliver care based on patient centricity, the multiple characteristics that shape the lives and health outcomes of the patient must be understood. This is especially true for clinical trial participation

Intersectionality is the framework for how a person’s relationships, identities, interactions, and interdependencies can create different advantages and disadvantages. Intersectionality in healthcare focuses on the ways multiple factors of social inequality overlap and compound.

Clarifying Perspective

Access pathways, barriers, lack of information, and historic and ongoing racism and discrimination contribute to underrepresentation of diverse groups in clinical trials. To increase diversity in clinicals, it is important to embrace the intersectionality of the patient to fully appreciate the patient’s journey and to better understand what is needed for the patient to successfully participate and access clinical trials.

For example, a mom who is an immigrant and teacher may face childcare, insurance coverage, and work flexibility challenges. Conversely, an elderly man who is non-English speaking and has preexisting conditions may be challenged by his caregiver’s schedule, as well as his own language barriers and comorbidities.

Intersectionality allows us to view our patients from a heterogenous perspective versus a homogenous perspective. This can help alleviate patient barriers and burdens as well as improve recruitment and retention in clinical trials, which leads to better representative data and analysis. Ultimately, embracing intersectionality can inform and enhance trial design and elevate safety and efficacy of drug development.

Applying Intersectionality

There are several ways sponsors can apply intersectionality to better address and serve patients' diverse experiences during clinical trials.

Sponsors can organize community roundtables to understand patients' and healthcare providers' perspectives. These conversations provide first-hand insight from a number of vantage points and can lead to actionable advice for how sponsors can be more holistic in their approach to clinical trial recruitment. Equally important is elevating cultural competency within organizations through training that can foster understanding of the different circumstances and factors affecting patients’ health outcomes and promote diversity, equity, and inclusion (DE&I).

Evaluating informed consent forms to examine how inclusive and accessible the forms are for various populations could also be a consideration. Some fundamental adjustments, such as making the form available in multiple languages, can widen the net for recruitment of more diverse participants

Intersectionality should also be considered during the clinical data management process, as the quality of data generated plays an important role in the outcome of study. The demographic form of electronic case report forms (eCRF) should collect data on race, ethnicity, gender, sexual orientation, and socioeconomic status. This will allow a more accurate representation of clinical trial participants.

Reevaluating Regulatory Standards

There’s been promising action from a regulatory perspective as industry standards continue to increase emphasis on integrating the concept of intersectionality for DE&I in clinical trials. For example:

Earlier this year, FDA issued new draft guidance for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S.¹ Previously, the FDA hosted a webinar introducing the Multi-Regional Clinical Trials Center’s guidance document and supplemental toolkit, which spotlights the importance of intersectionality in statistical analysis and in the definition of diversity.²

Others have made similar efforts. The CMS Office of Minority Health encourages cutting-edge proposals that explore intersectionality through its Health Equity Data Access Program. The American Psychological Association (APA) put out a call for papers in February 2022 for research with a focus on “Intersectionality in stigma and health research.”⁴

In PhRMA's response to the "Social Determinants of Health Caucus RFI" in September 2021, PhRMA utilized the framework of intersectionality to "encourage collection of data at intersections of characteristics" as a recommendation for improving health equity data collection and reporting.⁵

Lastly, scientific publications and journals are increasing demands for supplementary data that speaks to safety and efficacy across diverse populations. There has been a cross-publisher initiative of more than 50 publishers representing over 15,000 journals to promote reporting guidelines that bolster diversity data within scholarly publishing.⁶

Serving Patients Holistically

As strides are made during the recruitment process to attract more diverse patients, that same momentum must be reflected at the site level. Sponsors have the opportunity to make suggestions on ways to meet patients where they are. Some recommendations could include:

• Reflecting on the sites’ recruitment plans and outreach activities to determine what diverse populations might be missing. Ensure that recruitment strategies are informed by diverse patient preferences and communication pathways.
• Infuse intersectionality theory into diversity training for investigators and site staff. Supporting staff in understanding their own intersecting identities can inform the sites’ readiness to serve patients.
• Connect with local communities, organizations, and advocacy groups to provide resources and a referral network for patients belonging to different communities. Consider compiling a local directory where diverse patients can go for targeted support and/or learn about sites’ trials.
• Shape intentional questions and space for empathetic inquiry that encourage patients to openly share their diverse perspectives and experiences during visits or check-ins. Seek to understand patients from more than one perspective by centering their voices in engagements.
• Implement site support or specific accommodations for intersectional barriers that diverse patients might face during trial participation. This could be in the form of flexible hours or telehealth check-ins, travel or meal reimbursements, childcare options or reimbursements, on-site or virtual interpreters, or provisioned devices.

In order to fully embrace intersectionality and make meaningful impacts in clinical trial recruitment of diverse populations, the entire journey of the patient must be realized — every step of the way.

References

1. FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials | FDA
2. FDA Office of Minority Health and Health Equity webinar introducing MRCT Center’s “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Supplemental Toolkit - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
3. Health Equity Data Access Program | CMS
4. Call for papers: Intersectionality in stigma and health research (apa.org)
5. Final-SDOH-Caucus-RFI-Response-92121.pdf (phrma.org)
6. Minimum standards for inclusion and diversity for scholarly publishing

About The Author:

Inez Ruiz-White, Ph.D., is the R&D lead of diversity, equity, and inclusion at Otsuka Pharmaceutical. Ruiz-White leads efforts to enhance diversity in clinical trials and develop strategies that will cultivate a culture that exemplifies DE&I across all levels of the R&D organization.