Overcoming barriers in the design and implementation of clinical trials for acute kidney injury: a report from the 2020 Kidney Disease Clinical Trialists meeting.
AKI
biomarkers
machine learning
outcome
pragmatic trial
Journal
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
ISSN: 1460-2385
Titre abrégé: Nephrol Dial Transplant
Pays: England
ID NLM: 8706402
Informations de publication
Date de publication:
31 03 2023
31 03 2023
Historique:
received:
09
09
2021
medline:
4
4
2023
pubmed:
14
1
2022
entrez:
13
1
2022
Statut:
ppublish
Résumé
Acute kidney injury (AKI) is a growing epidemic and is independently associated with increased risk of death, chronic kidney disease (CKD) and cardiovascular events. Randomized-controlled trials (RCTs) in this domain are notoriously challenging and many clinical studies in AKI have yielded inconclusive findings. Underlying this conundrum is the inherent heterogeneity of AKI in its etiology, presentation and course. AKI is best understood as a syndrome and identification of AKI subphenotypes is needed to elucidate the disease's myriad etiologies and to tailor effective prevention and treatment strategies. Conventional RCTs are logistically cumbersome and often feature highly selected patient populations that limit external generalizability and thus alternative trial designs should be considered when appropriate. In this narrative review of recent developments in AKI trials based on the Kidney Disease Clinical Trialists (KDCT) 2020 meeting, we discuss barriers to and strategies for improved design and implementation of clinical trials for AKI patients, including predictive and prognostic enrichment techniques, the use of pragmatic trials and adaptive trials.
Identifiants
pubmed: 35022767
pii: 6505137
doi: 10.1093/ndt/gfac003
pmc: PMC10064977
doi:
Types de publication
Review
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
834-844Subventions
Organisme : NIDDK NIH HHS
ID : R01 DK093770
Pays : United States
Organisme : NIDDK NIH HHS
ID : UH3 DK114866
Pays : United States
Organisme : NIDDK NIH HHS
ID : U24 DK060990
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL085757
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK106962
Pays : United States
Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of the ERA.
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