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Jamie P Dwyer M.D.

Department: Medicine

Biography

My clinical expertise centers around kidney disease (in general) but specifically diabetic kidney disease and other glomerular lesions, including glomerulonephritis. I have also developed expertise in the evaluation, management, and prevention of kidney stones (nephrolithiasis).  My clinical research has focused on these areas as well, particularly on the design, conduct, and analysis of large-scale randomized clinical trials (RCT) in nephrology and hypertension, particularly in delaying the progression of chronic kidney disease (CKD). I am the Co-Director of the Vanderbilt Nephrology Clinical Trials Center, a founding part of the Vanderbilt Center for the Study of Kidney Disease. Additionally, I am an Officer of the Collaborative Study Group (CSG), a international, non-profit organization 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, medical monitoring, trial conduct, and safety.

My clinical research has focused on the design, conduct, and analysis of large-scale randomized clinical trials (RCT) in nephrology and hypertension, particularly in delaying the progression of chronic kidney disease (CKD). I am the Co-Director of the Vanderbilt Nephrology Clinical Trials Center, a founding part of the Vanderbilt Center for the Study of Kidney Disease. Additionally, I am an Officer of the Collaborative Study Group (CSG), a international, non-profit organization 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, medical monitoring, trial conduct, and safety. I have participated on numerous Protocol Design, M&M, and DSMB committees. I have served as the Medical Monitor for multiple compounds and trials, detailed below. To support my expertise in safe conduct of trials, I currently serve as the Vice-Chair of my University’s Health Science’s Institutional Review Board. I have analyzed renal safety signals in non-renal clinical trials presented to the FDA.  Additionally, 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.

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