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Clin J Am Soc Nephrol. 2015 May 7;10(5):894-902. doi: 10.2215/CJN.11541114. Epub 2015 Mar 4.

Cross-Disciplinary Biomarkers Research: Lessons Learned by the CKD Biomarkers Consortium.

Author information

1
University of California-San Francisco, San Francisco, California;
2
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania;
3
Northwestern University Feinberg School of Medicine, Chicago, Illinois;
4
Brigham and Women's Hospital, Boston, Massachusetts;
5
Mount Sinai Hospital, New York, New York;
6
University of Louisville, Louisville, Kentucky;
7
Johns Hopkins University, Baltimore, Maryland;
8
University of Minnesota, Minneapolis, Minnesota;
9
Tufts Medical Center, Boston, Massachusetts;
10
National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland;
11
Ohio State University, Columbus, Ohio;
12
Johns Hopkins University, Baltimore, Maryland; Cedars-Sinai Medical Center, Los Angeles, California;
13
Boston University, Boston, Massachusetts; and.
14
National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona rnelson@nih.gov.

Abstract

Significant advances are needed to improve the diagnosis, prognosis, and management of persons with CKD. Discovery of new biomarkers and improvements in currently available biomarkers for CKD hold great promise to achieve these necessary advances. Interest in identification and evaluation of biomarkers for CKD has increased substantially over the past decade. In 2009, the National Institute of Diabetes and Digestive and Kidney Diseases established the CKD Biomarkers Consortium (http://www.ckdbiomarkersconsortium.org/), a multidisciplinary, collaborative study group located at over a dozen academic medical centers. The main objective of the consortium was to evaluate new biomarkers for purposes related to CKD in established prospective cohorts, including those enriched for CKD. During the first 5 years of the consortium, many insights into collaborative biomarker research were gained that may be useful to other investigators involved in biomarkers research. These lessons learned are outlined in this Special Feature and include a wide range of issues related to biospecimen collection, storage, and retrieval, and the internal and external quality assessment of laboratories that performed the assays. The authors propose that investigations involving biomarker discovery and validation are greatly enhanced by establishing and following explicit quality control metrics, including the use of blind replicate and proficiency samples, by carefully considering the conditions under which specimens are collected, handled, and stored, and by conducting pilot and feasibility studies when there are concerns about the condition of the specimens or the accuracy or reproducibility of the assays.

KEYWORDS:

CKD; biomarkers; epidemiology; outcomes; quality control; risk factors

PMID:
25739849
PMCID:
PMC4422251
DOI:
10.2215/CJN.11541114
[Indexed for MEDLINE]
Free PMC Article

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