The nephrology field has witnessed significant advancements in treating both common and rare kidney diseases in recent years. These breakthroughs have energized the medical community and pharmaceutical industry to develop innovative therapies further. However, transitioning from development to clinical use, including executing phase 2 and phase 3 trials, remains challenging. One of the focal points in these trials is achieving recruitment goals and ensuring a diverse representation of clinical trial participants, including traditionally underrepresented groups.
Conducting research in community practices provides potential advantages in achieving this broad range of goals, as it integrates trials with patient care, enhancing trust and recruitment. The inclusion of varied patient scenarios enhances the applicability of findings to real-world medical settings, thereby forming a valuable link between research and clinical practice that stands to benefit a more diverse range of patients. “As a community, we work collaboratively to ensure the success of clinical trials through our partnership with FDA [U.S. Food and Drug Administration] via the Kidney Health Initiative and forums [in which] people with kidney diseases, trialists, industry sponsors, and clinicians can discuss and exchange ideas,” said Melissa West, ASN Senior Director for Strategic Relations and Patient Engagement. “ASN's efforts to accelerate innovation and expand patient choice require ‘building research readiness, inclusiveness, and translation in kidney medicine, which requires championing clinical trials.’ Adding the perspective of community practices, where people with kidney diseases receive their care would greatly enhance our discussions and potential for success” (1).
Community-based nephrology practices have yet to traditionally have the ability and capacity to build and sustain a clinical research program. We propose a framework based on our experiences as a potential guide to build more widespread community, nephrology-based clinical research programs (Figure 1).
The authors acknowledge the editorial support of Barbara Gillespie, MD, MMS, FASN, vice president and Therapeutic Head of Nephrology at Fortrea, Durham, NC.