Harmonizing test results for a global clinical trial

CLIENT: Leading provider of central laboratory services


Our client found that, when tested locally, many patients would meet the inclusion criteria for their study. When they were re-tested at the central laboratory, however, they no longer qualified (false positives). The challenge was to find a way to minimize the lab-to-lab variation in reported test results and to harmonize this data to the testing systems of the central laboratory.


First we assessed the accuracy of testing at all peripheral laboratory sites. We then compared these local test results with the results produced by the central laboratory and quantified the degree of variation. The final step was to have attending physicians apply a correction factor to the test results from the local lab and effectively ‘harmonize’ the local tests with those of the central lab. Our client then used these post-analytically corrected results to accurately assess whether or not a given patient qualifies for their study.