Laboratory data in clinical trials: a statistician's perspective.
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.
Chuang-Stein
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Pharmacia and Upjohn Company, Kalamazoo, Michigan 49001, USA.
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D015982:Bias; D015415:Biomarkers / Q000032:analysis*; D003625:Data Collection; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*
D015415:Biomarkers