Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease-Improving Global Outcomes (KDIGO) Controversies Conference

Baigent, C. et al. (2017) Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease-Improving Global Outcomes (KDIGO) Controversies Conference. Kidney International, 92(2), pp. 297-305. (doi: 10.1016/j.kint.2017.04.019) (PMID:28709600)

Abstract

Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled "Challenges in the Conduct of Clinical Trials in Nephrology" to identify the key barriers to conducting trials in patients with kidney disease. The conference began with plenary talks focusing on the key areas of discussion that included appropriate trial design (covering identification and evaluation of kidney and nonkidney disease outcomes) and sensible trial execution (with particular emphasis on streamlining both design and conduct). Break out group discussions followed in which the key areas of agreement and remaining controversy were identified. Here we summarize the main findings from the conference and set out a range of potential solutions. If followed, these solutions could ensure future trials among people with kidney disease are sufficiently robust to provide reliable answers and are not constrained by inappropriate complexities in design or conduct.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McMurray, Professor John
• Authors: Baigent, C., Herrington, W. G., Coresh, J., Landray, M. J., Levin, A., Perkovic, V., Pfeffer, M. A., Rossing, P., Walsh, M., Wanner, C., Wheeler, D. C., Winkelmayer, W. C., and McMurray, J. J.V.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Kidney International
• Publisher: Elsevier
• ISSN: 0085-2538
• ISSN (Online): 1523-1755
• Published Online: 12 July 2017
• Copyright Holders: Copyright © 2017 International Society of Nephrology
• First Published: First published in Kidney International 92(2): 297-305
• Publisher Policy: Reproduced under a Creative Commons license