Drug Development in Kidney Disease: Proceedings From a Multistakeholder Conference.

Tamara Isakova, Myles Wolf, Glenn M Chertow, Christina Wyatt, Navdeep Tangri, Lothar Roessig, David Polidori, Richard Nkulikiyinka, Maria E Montez-Rath, Daniel L Edmonston, Lesley A Inker, Ali Hariri, Tom Greene, Peter M DiBattiste, Laura M Dember, Paul T Conway, Geoffrey Block, Matthew T Roe

Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation 2020;76(6):842-850

PMID: 32768631

Full Text on Elsevier Science View on PubMed

Abstract

Occasional bursts of discovery and innovation have appeared during the otherwise stagnant past several decades of drug development in nephrology. Among other recent drug discoveries, the unexpected kidney benefits observed with sodium/glucose cotransporter 2 inhibitors may herald a renaissance of drug development in kidney disease. This recent progress highlights the need to further promote and stimulate research and development of promising therapies that may ameliorate the morbidity and mortality associated with kidney disease. To help identify and address barriers to drug development in nephrology, the Duke Clinical Research Institute convened a conference in April 2019 that included stakeholders from academia, industry, government agencies, and patient advocacy. From these discussions, several opportunities were identified to improve every stage of drug development for kidney disease from early discovery to implementation into practice. Key topics reviewed in this article are the utility of interconnected data and site research networks, surrogate end points, pragmatic and adaptive trial designs, the promising uses of real-world data, and methods to improve the generalizability of trial results and uptake of approved drugs for kidney-related diseases.

Address: Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: [email protected].; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.; Reata Pharmaceuticals, Inc, Irving, TX.; American Association of Kidney Patients, Tampa, FL.; Renal, Electrolyte, and Hypertension Division, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA; Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.; Janssen, Raritan, NJ.; University of Utah, Salt Lake City, UT.; Sanofi, Cambridge, MA.; Tufts Medical Center, Boston, MA.; Division of Nephrology, Department of Medicine, Northwestern Feinberg School of Medicine, Chicago, IL.; Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA.; Bayer AG, Pharmaceuticals, Research & Development, Wuppertal, Germany.; Janssen Research & Development, San Diego, CA.; University of Manitoba, Winnipeg, Canada.; Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.; Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA; Department of Health Research and Policy, Stanford University School of Medicine, Palo Alto, CA.

DOI: 10.1053/j.ajkd.2020.05.026

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MeSH Terms: Drug Approval, Drug Development, Humans, Kidney Diseases, Research Design, Adaptive Clinical Trials as Topic