Central Laboratory Interlaboratory Comparison Program To Assess The Comparability Of Data Of Tests From Four Regional Laboratories Involved In Global Clinical Trials

By Christopher R. Daniels, Ph.D., Venkat R. Rajagopal, M.S., and Traci Turner, M.D.

Objective: The objective of this study was to develop and support a process for assessing the comparability of data used in global clinical trials from four individual laboratories, wholly owned by the same central laboratory entity, and that the same tests on the same samples are under statistical control and acceptable limits of variation.