How to Successfully Develop Treatments for Early-Stage CKD: A Patient Perspective

Clinical Trial Considerations in Developing Treatments for Early Stages of Common, Chronic Kidney Diseases: A Scientific Workshop Cosponsored by the National Kidney Foundation and the US Food and Drug Administration

“…A total of 1,029 participants responded to the survey; full results of the survey are published elsewhere, along with a perspective from the patient member of the planning committee. 47,48 Three people participated in the panel, which is described in Item S2.…”

“…• Continued evaluation of the role of real-world evidence and registries to augment the understanding of the safety profile of a drug following approval • Continued evaluation of the size and duration of trials needed to obtain adequate information on a drug's risks before approval as a treatment for early-stage CKD we think the perspectives of these engaged individuals can provide guidance as to patients' values. 47,48 The variation in responses among both groups highlights the importance of individualizing benefit-risk discussions and for increased education and activation of patients earlier in the disease course. These discussions should recur over time to keep up with changes in health and life goals.…”