Involving Patients in the Design of Clinical Trials in Nephrology

Involving patients in the design of clinical trials improves the relevance, quality, and uptake of research and is increasingly expected by funders and regulators. To inform patient-centered practice and policy, trials must address research questions of high priority to patients and clinicians, test interventions that align with the needs and preferences of patients and are acceptable to them, and report outcomes of importance. Clinical trials in nephrology are largely driven by academia and industry with limited patient involvement and many do not address outcomes that are important to patients. In this article, we describe why and how to involve patients in designing clinical trials (Figure 1) using M-FIT (Structured exercise prograM to reduce fatigue In patients receiving dialysis: an adaptive Trial; ACTRN12620000408987) as an illustrative example and discuss the challenges and solutions for effective patient involvement in trial design based on the Patient-Centered Outcomes Research Institute framework.