Harmonization of laboratory results by data adjustment in multicenter clinical trials.

ABSTRACT:

Background/aims

In multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods.

Methods

We chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laborator

SUBMITTER: Lee SG 

PROVIDER: S-EPMC6234397 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature