Abstract: INFO18-SA
Redesigning Research: A Blueprint for Patient-Sponsor Co-creation and Collaboration Driving Science and Innovation in Clinical Trials
Session Information
- Informational Posters - 3
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Diversity and Equity in Kidney Health
- No subcategory defined
Authors
- Conway, Paul T., American Association of Kidney Patients, Tampa, Florida, United States
- Penn, Melissa, Bayer AG, Leverkusen, NRW, Germany
- Clynes, Diana, American Association of Kidney Patients, Tampa, Florida, United States
- Kahle, Erin, American Association of Kidney Patients, Tampa, Florida, United States
- Bailey, Jerome, American Association of Kidney Patients, Tampa, Florida, United States
- Goldsbury, David, Bayer plc, Reading, England, United Kingdom
- Lawatscheck, Robert, Bayer AG, Leverkusen, NRW, Germany
- Pena, Miguel A, Bayer Corporation, Whippany, New Jersey, United States
- Brinker, Meike Daniela, Bayer AG, Leverkusen, NRW, Germany
Description
The American Association of Kidney Patients (AAKP) Standing Patient Council (SPC) collaboration with Bayer was initiated in November 2021, soon after recruitment started for the FIND-CKD trial (NCT05047263). The goal of this SPC partnership was to enhance representation and improve patient experience in the Bayer CKD clinical trials program by benefitting the expertise, lived experiences, and innovative and strategic mindset from AAKP. The SPC designed content with Bayer, advised on trial materials, and recommended on recruitment strategies, retention, participant experience, and study closeout. This included co-creating patient-facing materials, return of individual data, and participant recognition and communications. Through this process, the group identified and transcended barriers to patient recruitment and improved study materials by using patient-appropriate language and addressing key areas that are important to patients when making enrollment decisions. Grassroots national ambassadors from AAKP supported trial awareness efforts via tailored outreach initiatives as a trusted source within their local patient community. A Bayer consultant and an appointed Diversity PI supported inclusive implementation. The SPC will be sustained through long-term follow-up.
The partnership model implemented in FIND-CKD became a blueprint and set a precedent for earlier SPC involvement in subsequent studies. In the FINE-ONE trial (NCT05901831), the SPC was involved before first patient, first visit and co-designed informed consent, study design, and trial conduct with Bayer. This approach yielded tangible impacts; FIND-CKD exceeded diversity targets and FINE-ONE exceeded U.S. recruitment goals. Further iterations of this co-creation model, applied to different studies, are launching before phase II and expanding globally, leading to the achievement of recruitment goals months ahead of schedule, as recently seen in another early-phase compound study.
This collaboration model offers a replicable path for ensuring continued, meaningful patient–sponsor partnership.
Funding
- Bayer AG