Dr. Lewis has outstanding expertise in the design and conduct of multi-center renal clinical trials and has had leadership roles in numerous NIH sponsored clinical trials. In these trials, in addition to being the principal investigator at the Vanderbilt high enrolling and high performing center she has had numerous leadership roles for the overall trial including serving on or leading the protocol design, form design, intervention, disease management, outcome classification and publication committees. She has played key roles in the Collaborative Study Group (CSG), an independent ARO, sitting on its executive committee for twenty years in charge of protocol development and more recently as Vice President. The CSG has been responsible for key clinical trials in nephrology leading to FDA approval of captopril and irbessrtan for diabetic nephropathy. More recently she led the clinical coordinating center, developed the protocol, forms and other key trial elements for the development of a novel phosphate binder the results of which have been submitted to the FDA. Currently, she serves as head of several NIH and industry sponsored oversight/advisory panels for other studies and sits on the cardio-renal FDA Advisory Board.