Abstract: FR-PO892
Challenges in Diversity and Inclusion in Clinical Trial Enrollment in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Session Information
- Diversity and Equity in Kidney Health - II
November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Diversity and Equity in Kidney Health
- 800 Diversity and Equity in Kidney Health
Authors
- Foy, Denise, Spherix Global Insights, Exton, Pennsylvania, United States
- Khan, Barbara Cristina, Palladio Biosciences, Horsham, Pennsylvania, United States
- Rex, Ryan, Spherix Global Insights, Exton, Pennsylvania, United States
Background
Increasing diversity and inclusion in clinical trials remains challenging in the ADPKD population, but opportunities exist to support expansion of representation among underserved populations.
Methods
Real world analysis conducted in Fall 2020 and 2021 evaluating more than 1,500 ADPKD patient charts (collected in collaboration with 243 US nephrologists). Additional data was collected via an online survey of 102 US nephrologists in May 2022.
Results
The large-scale chart audits revealed that the ADPKD patient population is 62% White, 18% African American/Black, 12% Hispanic, and 6% Asian. Socioeconomic status was categorized as primarily middle (61%) and upper class (14%), with only 16% identified as lower income. While two-thirds of survey respondents expressed a willingness to enroll patients into a new clinical trial, the data show the patients more likely to be targeted for enrollment are White, in a higher socioeconomic class, with advanced education, and with commercial insurance, revealing potential bias in patient selection for trials. In addition, the majority of respondents ranked “lower income” as the demographic most underrepresented in clinical trials, followed by Black and Hispanic populations (notably, 34% stated there is no unmet need in particular demographic groups). Barriers to patient enrollment included low trial awareness overall, difficulty in identifying appropriate patients, patient resistance and lack of trust, and the burden of managing the enrollment process.
Importantly, 65% of the surveyed physicians said that the FDA draft guidance to increase diversity in clinical trials would influence their decisions on which patients to recommend for a clinical trial. Almost all respondents identified several areas to improve participation in clinical trials, including better/more physician education about trials, patient incentives, easier enrollment processes, and more access to live coordinators and resources
Conclusion
Physicians need more resources and support to identify opportunities to refer patients to clinical trials and increase enrollment of a more diverse patient population. Compelling educational resources are needed to address barriers, especially those that disproportionately impact underrepresented patient groups.
Funding
- Commercial Support – Palladio Biosciences, Inc, a Centessa Pharmaceuticals company.