Jamie P.DwyerMD

Summary

• I am currently Professor of Medicine at the University of Utah in the Clinical and Translational Sciences Institute. My research focuses on the design, conduct, and analysis of large-scale randomized clinical trials in nephrology and hypertension, particularly in delaying the progression of CKD. I am the current President/PI of the Collaborative Study Group (CSG), a international academic research organization (ARO) dedicated to the exceptionally rigorous design and analysis and safe conduct of pilot and multinational, large-scale, pivotal RCTs in relevant therapeutic areas, including CKD, diabetic nephropathy, lupus, lupus nephritis, and end-stage renal disease. My expertise centers around protocol design and endpoint selection/design, medical monitoring, trial conduct, and safety. I have analyzed renal safety signals in non-renal clinical trials presented to FDA, as well as sat on FDA Advisory Committees. I am interested in investigating alternative, proximal outcomes in large RCTs in nephrology which will increase event rates, reduce follow-up time, and reduce sample sizes, in order to speed intervention development to delay the progression of CKD. Finally, as part of this interest in endpoint analysis, I am interested in the measurement of renal function and its implications for the design and choice of endpoints in large RCTs, particularly as it relates to assessment of nephrotoxicity ascertainment. I am a practicing nephrologist who cares for CKD and dialysis patients across the care continuum. In 2017, we founded Innovative Renal Care. Until 2022, I was Director of the Nephrology Clinical Trials Center at Vanderbilt University Medical Center.