@article{e57ad82c96294741b22211563863324d,
title = "Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference",
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.",
keywords = "kidney disease, randomized clinical trials, trial conduct, trial design",
author = "{KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants} and {KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants} and Colin Baigent and Herrington, {William G.} and Josef Coresh and Landray, {Martin J.} and Adeera Levin and Vlado Perkovic and Pfeffer, {Marc A.} and Peter Rossing and Michael Walsh and Christoph Wanner and Wheeler, {David C.} and Winkelmayer, {Wolfgang C.} and McMurray, {John J.V.} and Ali Abu-Alfa and Patrick Archdeacon and Block, {Geoffrey A.} and Caskey, {Fergus J.} and Cheung, {Alfred K.} and Bruce Cooper and Craig, {Jonathan C.} and Dember, {Laura M.} and Garabed Eknoyan and Gansevoort, {Ron T.} and Gill, {John S.} and Barbara Gillespie and Tom Greene and Harris, {David C.} and Richard Haynes and Hemmelgarn, {Brenda R.} and Herzog, {Charles A.} and Hiemstra, {Thomas F.} and Inker, {Lesley A.} and Jardine, {Meg J.} and Vivekanand Jha and Lixin Jiang and Johansen, {Kirsten L.} and Reshma Kewalramani and {Lambers Heerspink}, {Hiddo J.} and Martin Lefkowitz and Lok, {Charmaine E.} and Fiona Loud and Romaldas Ma{\v c}iulaitis and Maddux, {Dugan W.} and Maddux, {Franklin W.} and Magdalena Madero and Segundo Mariz and Michael Mauer and Nally, {Joseph V.} and Masaomi Nangaku and Toto, {Robert D.}",
note = "Publisher Copyright: {\textcopyright} 2017 International Society of Nephrology",
year = "2017",
month = aug,
doi = "10.1016/j.kint.2017.04.019",
language = "English (US)",
volume = "92",
pages = "297--305",
journal = "Kidney international",
issn = "0085-2538",
publisher = "Nature Publishing Group",
number = "2",
}