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

2017; Elsevier BV; Volume: 92; Issue: 2 Linguagem: Inglês

10.1016/j.kint.2017.04.019

1523-1755

Colin Baigent, William G. Herrington, Josef Coresh, Martin Landray, Adeera Levin, Vlado Perkovic, Marc A. Pfeffer, Peter Rossing, Michael Walsh, Christoph Wanner, David C. Wheeler, Wolfgang C. Winkelmayer­, John J.V. McMurray, Ali K. Abu‐Alfa, Patrick Archdeacon, Geoffrey A. Block, Fergus Caskey, Alfred K. Cheung, Bruce A. Cooper, Jonathan C. Craig, Laura M. Dember, Garabed Eknoyan, Ron T. Gansevoort, John S. Gill, Barbara S. Gillespie, Tom Greene, David C.H. Harris, Richard Haynes, Brenda R. Hemmelgarn, Charles A. Herzog, Thomas F. Hiemstra, Lesley A. Inker, Meg Jardine, Vivekanand Jha, Lixin Jiang, Kirsten L. Johansen, Reshma Kewalramani, Hiddo J.L. Heerspink, Martin Lefkowitz, Charmaine E. Lok, Fiona Loud, Romaldas Mačiulaitis, Dugan Maddux, Franklin W. Maddux, Magdalena Madero, Segundo Mariz, Michael Mauer, Joseph V. Nally, Masaomi Nangaku, Ikechi G. Okpechi, Patrick S. Parfrey, Roberto Pécoits-Filho, Brian J.G. Pereira, Michael V. Rocco, Patrick Rossignol, Franz Schaefer, Francesca Tentori, Aliza Thompson, Marcello Tonelli, Allison Tong, Robert D. Toto, Katherine R. Tuttle, Thorsten Vetter, Angela Yee‐Moon Wang, Faı̈ez Zannad,

Dialysis and Renal Disease Management

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.