Pragmatic clinical trials in CKD: Opportunities and challenges

American Society of Nephrology Chronic Kidney Disease Advisory Group

Research output: Contribution to journalReview article

21 Scopus citations

Abstract

Randomized controlled trials in CKD lag in number behind those of other chronic diseases, despite the high morbidity and mortality experienced by patients with kidney disease and the exorbitant costs of their health care. Observational studies of CKD frequently yield seemingly paradoxic associations of traditional risk factors with outcomes, making it difficult to extrapolate the results of trials conducted in people with normal kidney function to patients with CKD. However, many completed trials in CKD have been limited by intermediate outcomes of unclear clinical significance or narrow eligibility criteria that limit external validity, and implementation of proven therapies remains a challenge. It is therefore imperative that the nephrology community capitalize on recent interest in novel approaches to trial design, such as pragmatic clinical trials. These trials are meant to promote research within real world settings to yield clinically relevant results with greater applicability than those of traditional trials, while maintaining many advantages, such as controlling for potential sources of bias. We provide a description of pragmatic clinical trials and a discussion of advantages, disadvantages, and practical challenges inherent to this study design, in the context of specific scientific questions relevant to patients with CKD.

Original languageEnglish (US)
Pages (from-to)2948-2954
Number of pages7
JournalJournal of the American Society of Nephrology
Volume27
Issue number10
DOIs
StatePublished - 2016

ASJC Scopus subject areas

  • Nephrology

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    American Society of Nephrology Chronic Kidney Disease Advisory Group (2016). Pragmatic clinical trials in CKD: Opportunities and challenges. Journal of the American Society of Nephrology, 27(10), 2948-2954. https://doi.org/10.1681/ASN.2015111264