Work

Biomarkers and Surrogate Endpoints in Renal Transplantation: Present Status and Considerations for Clinical Trial Design

Year: 2004

Type: review

Abstract: 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.

Source: American Journal of Transplantation

DOI: 10.1111/j.1600-6143.2004.00386.x

Authors: Peter A. Lachenbruch, Amy S. Rosenberg, Ezio Bonvini, Marc W. Cavaillé-Coll, Robert B. Colvin

Institutions: Center for Biologics Evaluation and Research, United States Food and Drug Administration, Center for Drug Evaluation and Research, Harvard University, Massachusetts General Hospital

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,300