Cross-Disciplinary Biomarkers Research: Lessons Learned by the CKD Biomarkers Consortium.
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.
University of California-San Francisco, San Francisco, California;
Chi-Yuan
CY
Hsu
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania;
Shawn
S
Ballard
Northwestern University Feinberg School of Medicine, Chicago, Illinois;
Daniel
D
Batlle
Brigham and Women's Hospital, Boston, Massachusetts;
Joseph V
JV
Bonventre
Mount Sinai Hospital, New York, New York;
Erwin P
EP
Böttinger
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania;
Harold I
HI
Feldman
University of Louisville, Louisville, Kentucky;
Jon B
JB
Klein
Johns Hopkins University, Baltimore, Maryland;
Josef
J
Coresh
University of Minnesota, Minneapolis, Minnesota;
John H
JH
Eckfeldt
Tufts Medical Center, Boston, Massachusetts;
Lesley A
LA
Inker
National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland;
Paul L
PL
Kimmel
National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland;
John W
JW
Kusek
University of California-San Francisco, San Francisco, California;
Kathleen D
KD
Liu
University of Minnesota, Minneapolis, Minnesota;
Michael
M
Mauer
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania;
Theodore E
TE
Mifflin
Northwestern University Feinberg School of Medicine, Chicago, Illinois;
Mark E
ME
Molitch
University of Minnesota, Minneapolis, Minnesota;
Gary L
GL
Nelsestuen
Johns Hopkins University, Baltimore, Maryland;
Casey M
CM
Rebholz
Ohio State University, Columbus, Ohio;
Brad H
BH
Rovin
Brigham and Women's Hospital, Boston, Massachusetts;
Venkata S
VS
Sabbisetti
Johns Hopkins University, Baltimore, Maryland; Cedars-Sinai Medical Center, Los Angeles, California;
Jennifer E
JE
Van Eyk
Boston University, Boston, Massachusetts; and.
Ramachandran S
RS
Vasan
Brigham and Women's Hospital, Boston, Massachusetts;
Sushrut S
SS
Waikar
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania;
Krista M
KM
Whitehead
National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona rnelson@nih.gov.
Robert G
RG
Nelson
D015415:Biomarkers; D035843:Biomedical Research / Q000592:standards; D006801:Humans; D058025:Interdisciplinary Studies; D011786:Quality Control; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000628:therapy; D013048:Specimen Handling / Q000592:standards*
D015415:Biomarkers
CKD; biomarkers; epidemiology; outcomes; quality control; risk factors