Biomarkers and surrogate endpoints in renal transplantation:: Present status and considerations for clinical trial design

被引：54

作者：

Lachenbruch, PA

Rosenberg, AS ^{[1
]}

Bonvini, E

Cavaillé-Coll, MW

Colvin, RB

机构：

[1] US FDA, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, Div Therapeut Prot, Bethesda, MD 20892 USA

[2] US FDA, Ctr Biol Evaluat & Res, Off Therapeut Res & Review, Div Monoclonal Antibodies, Bethesda, MD 20892 USA

[3] US FDA, Ctr Biol Evaluat & Res, Off Biostat & Epidemiol, Div Biostat, Bethesda, MD 20892 USA

[4] US FDA, Ctr Drug Evaluat & Res, Off New Drugs, Div Special Pathogen & Immunol Drug Prod, Rockville, MD USA

[5] Massachusetts Gen Hosp, Dept Pathol, Boston, MA 02114 USA

[6] Harvard Univ, Sch Med, Boston, MA 02114 USA

来源：

AMERICAN JOURNAL OF TRANSPLANTATION | 2004年 / 4卷 / 04期

关键词：

allograft rejection; predictive variables; surrogate endpoints;

D O I：

10.1111/j.1600-6143.2004.00386.x

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

Of major importance in clinical trials is the ability to predict individual patient outcome or endpoints using biomarkers, also known as variables or predictors, in as safe, efficient, and accurate a manner as possible. This review addresses the concepts and possible strategies for use of predictor and surrogate biomarkers in the design of clinical trials in renal transplantation. The statistical concepts apply equally well to other organ grafts.

引用

页码：451 / 457

页数：7

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