P27: Diversity in Clinical Research: Portfolio of Solutions to Broaden Access for Expanded Racial and Ethnic Representation
Poster Presenter
Lloryn Hubbard
Associate Director, Patient Diversity
PPD United States
Objectives
Homogeneous data sets inhibit our ability to improve care for all patients. We developed practical, evidenced-based tools to operationalize inclusive study execution. Our goal is to share our insights so that other study teams may implement similar strategies.
Method
We leveraged health disparity literature, internal data and external guidance from thought leaders focused on health disparities to develop over 30 actionable inclusive research tactics that are organized by the life cycle of a clinical trial. Of these, 5 areas were prioritized to assess impact.
Results
The expert reviewers identified 5 areas with the potential to have the highest impact on increasing diverse representation in clinical trials. These areas include: 1) financial burden to the patient, 2) assumptions and bias of site staff regarding patients of color, 3) slte location and capabilities, 4) health literacy of patients and their families, and 5) trust concerns of clinical trial participation in patients. The internal cross-functional team then developed a tactical toolkit of over 30 actionable inclusive research tactics organized in an accessible map with resources that span the clinical trial study lifecycle. The toolkit was socialized to 3 clinical operations organizations across the business covering early development through late stage trials. Study teams implementing trials in disease areas with a higher relative prevalence of disease in underrepresented/understudied patient populations and where there are known population specific differences in outcomes (i.e. COVID-19, Lupus, Multiple Sclerosis) were prioritized to pilot the toolkit and to gain insights regarding tool utility and impact. In addition, case studies were generated from these target studies to further share learnings with non-prioritized therapeutic areas. Supporting internal analytics teams have provided site performance historical baseline data to enable tracking of progress in diverse recruitment. Analytics will also support standardized data points, and incorporation of feedback to evolve solutions. Of the targeted studies, Financial mitigation, early translations of ICFs and supporting documents, adjusted demographic feasibility questions, data driven site selection, and a high touch Medical Monitor engagement with Principal Investigators were identified as the most used and well received actionable tactics by study teams to support more representative patient enrollment.
Conclusion
The Portfolio of Solutions is a standardized resource to embed inclusive research tools and resources into trial operations across the study lifecycle. Study teams have reported that the Portfolio of Solutions has increased the awareness of these inclusive research tools and tactics which is an important strategy to drive utilization. The socialization of the toolkit has also impacted the mindset of study teams across the organization to implement actionable tools that meet the news of the study lifecycle. We found that concerns of inclusive research tactics negatively impacting timeline and budget have been mitigated by sharing case studies demonstrating that adoption of inclusive research tools and resources can improve recruitment goals without impacting the overall study budget. As more teams adopt the Portfolio of Solutions we are collaborating with our analytics teams to define metrics, standardize data points and incorporate feedback so that we may evolve solutions as we drive inclusive research across the organization.
