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

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Colin Baigent, William G. Herrington, Josef Coresh, Martin J. Landray, Adeera Levin, Vlado Perkovic, Marc A. Pfeffer, Peter Rossing, Michael Walsh, Christoph Wanner, David C. Wheeler, Wolfgang C. Winkelmayer, John J.V. McMurray, KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants, Ali Abu-Alfa, Patrick Archdeacon, Geoffrey A. Block, Fergus J. Caskey, Alfred K. Cheung, Bruce Cooper & 31 andre Jonathan C. Craig, Laura M. Dember, Garabed Eknoyan, Ron T. Gansevoort, John S. Gill, Barbara Gillespie, Tom Greene, David C. Harris, Richard Haynes, Brenda R. Hemmelgarn, Charles A. Herzog, Thomas F. Hiemstra, Lesley A. Inker, Meg J. Jardine, Vivekanand Jha, Lixin Jiang, Kirsten L. Johansen, Reshma Kewalramani, Hiddo J. Lambers Heerspink, Martin Lefkowitz, Charmaine E. Lok, Fiona Loud, Romaldas Mačiulaitis, Dugan W. Maddux, Franklin W. Maddux, Magdalena Madero, Segundo Mariz, Michael Mauer, Joseph V. Nally, Masaomi Nangaku, Ikechi G. Okpechi

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.

TidsskriftKidney International
Udgave nummer2
Sider (fra-til)297-305
Antal sider9
StatusUdgivet - 2017

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