PMID: 9551281Apr 29, 1998Paper

Laboratory data in clinical trials: a statistician's perspective

Controlled Clinical Trials
C Chuang-Stein

Abstract

Even though laboratory data provide the best indicators for systemic toxicities in clinical trials of investigational medications, many applied statisticians lack a basic understanding of the interpretation of such data. Understanding is essential to a statistician's ability to help evaluate a patient's overall safety experience in a trial, the latter being the primary objective for collecting laboratory data in the trial. In this paper, we discuss the purpose of conducting laboratory evaluations as well as some hidden issues concerning the current practice of laboratory data analysis. The issues include the use of reference ranges, the one-parameter-at-a-time approach, and the exploratory nature of safety data analyses.

References

Jan 1, 1979·Reviews of Infectious Diseases·K R BrownF M Ricci
Jun 15, 1992·Statistics in Medicine·C Chuang-SteinD M Musselman
May 1, 1991·Statistics in Medicine·P Royston, J N Matthews
May 1, 1972·Journal of Chronic Diseases·F Ederer

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Citations

Dec 5, 2009·Journal of Biomedical Informatics·David P ChenAtul J Butte
Mar 13, 2002·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·John P A Ioannidis, Joseph Lau
May 8, 1999·The American Journal of Clinical Nutrition·B CartmelN Levine

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