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P120: A Novel Approach: Leveraging the “Affective Trust Framework” to Develop a Sponsor-specific Clinical Trial Diversity Playbook

Poster Presenter

Camille Pope

Chief Medical Lead
Acclinate Inc.
United States

Objectives

This thought-leadership poster offers 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-specific approach for addressing clinical trial diversity.

Method

The “Affective Trust Framework” forms the foundation of the playbook. A review of FDA guidance, laws on diversity planning, and TA-specific resources is then paired with an organizational gap analysis to develop an approach for achieving clinical trial diversity that is sponsor-specific.

Results

The “Affective Trust Framework,” which focuses on elements of inclusive trial design, sustained community engagement with historically underrepresented populations, and trust-enabling technology, serves as the foundation for the clinical trial diversity playbook. Then, using the oncology TA as a use-case, an assessment of FDA guidance documents, the Food & Drug Omnibus Reform Act (FDORA), trade organization “industry best practice” references, and clinical trial diversity recommendations from the American Association for Cancer Research (AACR), American Society for Clinical Oncology (ASCO), and American Society for Hematology (ASH) yields recommendations specific to improving diversity in oncology clinical trials that can be layered on top of the initial framework. These recommendations may include (but are not limited to) suggestions on which critical components to consider for a diversity plan submission to regulatory authorities, as well as advice for improving health literacy and upskilling community oncology practices as research sites. Lastly, an organizational gap analysis of the research sponsor’s current approach to trial diversity, including a review of the sponsor’s internal/external prioritization of trial diversity and feedback from employee interviews, results in sponsor-specific recommendations for achieving diversity in the sponsor’s oncology clinical trials. For example, outputs from the organizational gap-analysis may include revisions to the sponsor’s clinical development planning templates, addition of race/ethnic 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.

Conclusion

The “Affective Trust Framework” asserts that inclusive trial design, sustained community engagement, and trust-enabling technology are foundational to achieving clinical trial diversity. New laws and recent regulatory guidance that require submission of diversity plans to the FDA prior to pivotal trial kick-off have led research sponsors to reassess their current approaches for including historically underrepresented patient populations in their studies. By leveraging the “Affective Trust Framework,” and then layering insights gleaned from the FDA, recommendations from TA-specific resources, and a critical review of organizational gaps on top of the framework, sponsors are able to create step-by-step playbooks specific to their organizations for improving clinical trial diversity. While the use-case provided in this poster is for oncology, a similar approach may be applied across different TAs and sponsors, with the expectation of generalizable yet nuanced outcomes that aid in playbook development. Additional Authors: Delmonize Smith, PhD; Tiffany Whitlow; Shayla Wilson, MPH