A Novel Approach: Leveraging the Affective Trust Framework
Developing a Sponsor-Specific Clinical Trial Diversity Playbook
Camille Pope, Shayla Wilson, Tiffany Whitlow, Del Smith
Acclinate, Inc.
T

here is increasing agreement that aiming for health equity through inclusive clinical research is in the best interest of patients. This renewed focus from research sponsors on diversifying their clinical trials has also been driven by new laws (i.e., the December 2022 Food and Drug Omnibus Reform Act – FDORA, sections 3601-3604) and regulatory guidance (i.e., the April 2022 FDA Draft Guidance to Industry on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials) that require submission of diversity plans to FDA prior to the start of pivotal studies.

Regardless of the governmental catalyst or motivational factors, research sponsors are reassessing their approach for including historically underrepresented patient populations, particularly from communities of color, in their clinical trials. The key question they should ask themselves is whether their strategies are truly positioned for success when it comes to engaging communities that they have previously excluded or ignored.

This article provides novel guidance to research sponsors on how to use “affective” (i.e., emotion-based) trust, regulatory guidance, organizational assessment, and therapeutic area (TA) considerations to develop a sponsor- and TA-specific playbook for addressing clinical trial diversity.

The Foundation

We have designed the Affective Trust Framework for Clinical Trial Diversity, which serves as the foundation for the clinical trial diversity playbook. The framework consists of three key pillars (see Figure 1) focused on elements of inclusive study design, sustained (“affective”) community engagement with historically excluded populations, and trust-enabling technology. At its core, this framework recognizes that for research sponsors to impactfully engage communities of color, they must first establish emotion-based affective trust.

Affective trust is steeped in genuine concern and personal goodwill toward underrepresented populations, whereas cognitive trust is based solely on rationality, data, and evidence. Cultivating affective trust requires sponsors to build relationships with historically excluded populations by seeking to understand that community’s lived experiences, by engaging with culturally competent community influencers who can share information about various disease states and research opportunities, and by investing in the community’s general health and wellness. A mix of in-person engagement plus trust- enabling technology (e.g., social media, email/text campaigns, predictive analytics) serves to sustain these relationships by facilitating broader outreach and identifying which community members may actually be willing to participate in clinical trials. Without affective trust, communities of color are less likely to participate in or maintain involvement in clinical research.

Affective Trust Framework for Clinical Trial Diversity title floating above three dark blue rectangular shaped boxes that include primary categorial topics such as Inclusive Study Design, Affective Community Engagement*, and Trust-Enabling Technology plus other secondary subcategorical topics after followed by three different asterik denotations at very bottom

The Process

Research sponsors should be methodical in the review of best practices for their playbook and be intentional and honest with themselves when conducting their organizational gap analysis (defined below in Figure 2), even if these findings make them uncomfortable. This process will allow them to identify areas for internal improvement before drafting and executing their diversity plan externally.
Four different yellow rectangular shaped boxes with the primary title floating up above labeled Begin with the Affective Trust Framework as the foundation followed by secondary titles Review industry best practices, Conduct an organizational gap analysis (sponsor/TA-specific considerations), and Develop the sponsor/TA-specific clinical trial diversity playbook as all these secondary titles have bullet point descriptions underneath them

An Oncology Use Case

This use case describes the development of a playbook for a research sponsor with oncology as the TA of interest. Assessing these FDA guidance documents, FDORA, and “industry best practices” from such trade organizations as the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, and combining them with clinical trial diversity recommendations from the American Association for Cancer Research, American Society of Clinical Oncology, Association of Community Cancer Centers, and the American Society of Hematology, yields recommendations specific to improving diversity in oncology clinical trials that can be layered on top of the initial Affective Trust Framework.

Recommendations may include suggestions on which key components to consider for diversity plan submission to the FDA, as well as advice for improving culturally tailored health literacy, for leveraging digital means and community partnerships (i.e., activation points) to extend reach, and for upskilling community oncology practices to become research sites.

In addition, an organizational gap analysis of the sponsor’s current approach to trial diversity, including a review of the sponsor’s internal/external prioritization of it and feedback from employee interviews, results in sponsor-specific recommendations for achieving diversity in the sponsor’s oncology clinical trials. Outputs from this organizational gap analysis may include revisions to the sponsor’s clinical development planning templates, addition of race/ethnicity demographic questions to study-specific site feasibility questionnaires, consideration of “up-and-coming” oncology researchers with diverse backgrounds for protocol steering committees/investigator opportunities, and new cross-functional team collaborations to facilitate broader understanding of the sponsor’s clinical trial diversity goals within the organization.

So, What Now?

Research sponsors must commit to developing clinical trial diversity playbooks specific to their goals and needs. By leveraging the Affective Trust Framework and then layering insights gleaned from regulators, recommendations from TA-specific resources, and from critical review of organizational gaps on top of this framework, sponsors can identify their shortcomings and make recommendations that set them up for successful implementation of trial diversity initiatives. An approach like the oncology use case described in this article can be applied across different TAs and sponsors to generate generalizable yet nuanced outcomes that aid in playbook development. While this approach may take time and forethought, the ultimate beneficiaries will be historically underrepresented communities who can have increased confidence that sponsors put forth genuine effort to include them in clinical research.
Back to Issue