Designing and implementing ePCTs with health equity in mind is essential to ensuring that research is generalizable to diverse individuals, groups, and communities—and that all have the opportunity to benefit from advances generated through this science. Clinical trials continue to have challenges related to representation of certain groups, and there remain inequalities in access to healthcare, funding mechanisms that do not accommodate research in community settings, and lack of infrastructure for research in settings outside of academic health centers. “We know there are inequities in access to healthcare to begin with so if we are not thoughtful about the integration of pragmatic clinical trials within a system that already lacks accessibility to many populations, I think that is a huge challenge that we need to overcome.” (presentation from Dr. Rosa Gonzalez-Guarda)

In the video below, Drs. Rosa Gonzalez-Guarda, Rachel Gold, and Karen A. Kehl discuss the importance of including diverse participants in pragmatic clinical trials and the challenges investigators and community health centers face engaging underrepresented populations in research.

Planning the ePCT through a health equity lens involves assessing the limitations, flaws, and biases that can affect representation, willingness to participate, adherence, and outcomes, among other aspects of the trial. In this video, Dr. Jonathan Jackson of Harvard Medical School uses the nine PRECIS-2 domains to illustrate important considerations for health equity, which must be front and center when designing and implementing PCTs.

Why Is Health Equity Important in Pragmatic Clinical Trials? (12:50)

Planning for Diversity in PCTs

Partner engagement is central to planning for diverse representation in ePCTs, especially the engagement from groups historically underrepresented in research such as racial and ethnic minorities. This level of engagement can be planned according to a continuum that ranges from outreach to shared leadership. One approach commonly used to maximize diversity in an ePCT is establishing a study advisory board with partners from health center leadership, patient advocates, legislators, and community leaders. Sharing information and resources with community partners—and responding to their priorities and building their capacity—helps to foster trust around medicine and research. On the continuum of community engagement, a particular collaboration may evolve over time into “long-term partnerships that move from the traditional focus on a single health issue to address a range of social, economic, political, and environmental factors that affect health” (from Principles of Community Engagement).

Sustainability also must be planned at the outset and will involve targeted, specific efforts to ensure the inclusion of diverse populations in clinical trials. PIs from two NIH Collaboratory Trials presented their efforts in selecting sites and engaging partners to maximize diversity. BeatPain Utah (Dr. Julie Fritz, PI) is designed to reduce disparities in pain prevalence and pain management through nonpharmacologic care in rural, low income, and Latinx communities. The team considered different types of partners while planning the study:

• Network partners to maintain contact for information sharing, dissemination, and recruitment.
• Development partners to build relationships toward potential projects/proposals and communicate on shared priorities and opportunities.
• Research partners for long-term, formal partnerships for research programs and shared decision-making.

STOP CRC (Drs. Gloria Coronado and Beverly Green, co-PIs) was designed to increase rates of colorectal cancer screening in minoritized and low-income populations. The study team emphasized establishing partnerships based on mutual respect to leverage local knowledge and produce meaningful results.

Together, these videos describe the characteristics of successful research partnerships and how to design research programs for sustainability within a community:

Planning for Diversity: BeatPain Utah

Planning for Diversity: STOP CRC

Outreach, Trust, and Consent

To maximize diversity in study enrollment, investigators should consider specific approaches for patient outreach, building trust, and obtaining consent. Study enrollment bias (where participants are reflective of a group of people and not reflective of the entire population with a disease) can occur beyond the participant level. “Healthy worker bias” can occur at the level of the healthcare system too, where bias exists due to demographics and other social and economic factors regarding the group of people who seek care at a system. A community-based participatory research model in the design of the study can assist in addressing barriers and build trust.

Consider including practices such as these to enhance enrollment:

• Tailored, personalized outreach and community connections
• Bilingual, bicultural staff
• Balancing fidelity with feasibility and relatability
• Cultural and linguistic adaptation
• Flexible scheduling

PIs from two NIH Collaboratory Trials presented their efforts to maximize diversity by meeting participants where they are. Dr. Stacy Sterling discusses a pilot study to explore the feasibility of implementing a universal prevention curriculum for Spanish-speaking families of young adolescents, a supplement to GGC4H (Guiding Good Choices for Health). Dr. Judith Schlaeger discusses the use of community-based participatory research practices in the GRACE trial, a study to treat pain from sickle cell disease with guided relaxation and acupuncture.

Guiando Buenas Decisiones: Implementing GGC4H for Spanish-Speaking Families

Community-Based Participatory Research Practices in the GRACE Trial

Developing Future Researchers

Creating and sustaining diverse researchers and research teams is critical to supporting and encouraging diversity and inclusion in ePCTs. Networks for early career underrepresented groups can foster the next generation of ePCT scientists. Primary care providers and community health workers are valuable to clinical research, and funding opportunities should be provided to these groups performing important work.

In these videos, Dr. George Mensah of the National Heart, Lung, and Blood Institute (NHLBI) offers an NHLBI perspective on developing future diverse investigators and leaders in ePCTs, and Dr. Natalia Morone, PI of OPTIMUM, a NIH Collaboratory Trial to incorporate mindfulness-based stress reduction in primary care to treat chronic low back pain, provides a an investigator’s perspective.

Developing a Pipeline of Diverse Investigators and Leaders in Pragmatic Clinical Trials: Perspectives From the NHLBI

Developing a Pipeline of Diverse Investigators: An Investigator Perspective