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

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; 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

doi:10.1016/j.kint.2017.04.019

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

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 CooperJonathan 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

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

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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.

Originalsprog	Engelsk
Tidsskrift	Kidney International
Vol/bind	92
Udgave nummer	2
Sider (fra-til)	297-305
Antal sider	9
ISSN	0085-2538
DOI	https://doi.org/10.1016/j.kint.2017.04.019
Status	Udgivet - 2017

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10.1016/j.kint.2017.04.019Licens: CC BY

1-s2.0-S0085253817303113-mainForlagets udgivne version, 210 KBLicens: CC BY

Citationsformater

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., McMurray, J. J. V., KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants, Abu-Alfa, A., Archdeacon, P., Block, G. A., Caskey, F. J., Cheung, A. K., ... Okpechi, I. G. (2017). Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference. Kidney International, 92(2), 297-305. https://doi.org/10.1016/j.kint.2017.04.019

Baigent, C, Herrington, WG, Coresh, J, Landray, MJ, Levin, A, Perkovic, V, Pfeffer, MA, Rossing, P, Walsh, M, Wanner, C, Wheeler, DC, Winkelmayer, WC, McMurray, JJV, KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants, Abu-Alfa, A, Archdeacon, P, Block, GA, Caskey, FJ, Cheung, AK, Cooper, B, Craig, JC, Dember, LM, Eknoyan, G, Gansevoort, RT, Gill, JS, Gillespie, B, Greene, T, Harris, DC, Haynes, R, Hemmelgarn, BR, Herzog, CA, Hiemstra, TF, Inker, LA, Jardine, MJ, Jha, V, Jiang, L, Johansen, KL, Kewalramani, R, Lambers Heerspink, HJ, Lefkowitz, M, Lok, CE, Loud, F, Mačiulaitis, R, Maddux, DW, Maddux, FW, Madero, M, Mariz, S, Mauer, M, Nally, JV, Nangaku, M & Okpechi, IG 2017, 'Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference', Kidney International, bind 92, nr. 2, s. 297-305. https://doi.org/10.1016/j.kint.2017.04.019

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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 = "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 {KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants} 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 Okpechi, {Ikechi G.}",

year = "2017",

doi = "10.1016/j.kint.2017.04.019",

language = "English",

volume = "92",

pages = "297--305",

journal = "Kidney International",

issn = "0085-2538",

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T1 - Challenges in conducting clinical trials in nephrology

T2 - conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference

AU - Baigent, Colin

AU - Herrington, William G.

AU - Coresh, Josef

AU - Landray, Martin J.

AU - Levin, Adeera

AU - Perkovic, Vlado

AU - Pfeffer, Marc A.

AU - Rossing, Peter

AU - Walsh, Michael

AU - Wanner, Christoph

AU - Wheeler, David C.

AU - Winkelmayer, Wolfgang C.

AU - McMurray, John J.V.

AU - KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants

AU - Abu-Alfa, Ali

AU - Archdeacon, Patrick

AU - Block, Geoffrey A.

AU - Caskey, Fergus J.

AU - Cheung, Alfred K.

AU - Cooper, Bruce

AU - Craig, Jonathan C.

AU - Dember, Laura M.

AU - Eknoyan, Garabed

AU - Gansevoort, Ron T.

AU - Gill, John S.

AU - Gillespie, Barbara

AU - Greene, Tom

AU - Harris, David C.

AU - Haynes, Richard

AU - Hemmelgarn, Brenda R.

AU - Herzog, Charles A.

AU - Hiemstra, Thomas F.

AU - Inker, Lesley A.

AU - Jardine, Meg J.

AU - Jha, Vivekanand

AU - Jiang, Lixin

AU - Johansen, Kirsten L.

AU - Kewalramani, Reshma

AU - Lambers Heerspink, Hiddo J.

AU - Lefkowitz, Martin

AU - Lok, Charmaine E.

AU - Loud, Fiona

AU - Mačiulaitis, Romaldas

AU - Maddux, Dugan W.

AU - Maddux, Franklin W.

AU - Madero, Magdalena

AU - Mariz, Segundo

AU - Mauer, Michael

AU - Nally, Joseph V.

AU - Nangaku, Masaomi

AU - Okpechi, Ikechi G.

PY - 2017

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N2 - 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.

AB - 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.

KW - kidney disease

KW - randomized clinical trials

KW - trial conduct

KW - trial design

U2 - 10.1016/j.kint.2017.04.019

DO - 10.1016/j.kint.2017.04.019

M3 - Journal article

C2 - 28709600

AN - SCOPUS:85024388262

SN - 0085-2538

VL - 92

SP - 297

EP - 305

JO - Kidney International

JF - Kidney International

IS - 2

ER -

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

Abstract

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