Article
Validating pathophysiological models of aging using clinical electronic medical records.
Center for Biomedical Informatics Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, USA.
Journal of Biomedical Informatics (impact factor:
1.79).
11/2009;
43(3):358-64.
DOI:10.1016/j.jbi.2009.11.007
pp.358-64
Source: PubMed
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Article: Laboratory data in clinical trials: a statistician's perspective.
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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.Controlled Clinical Trials 04/1998; 19(2):167-77.
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Keywords
2002 National Health
academic tertiary-care pediatric hospital
adolescent chronological age
alkaline phosphatase
cell volume
clinical data
clinical data promises
clinical differences
clinically relevant
cross-sectional cohorts
female models
females
molecular mechanisms
Nutrition Examination Survey
predictive biomarkers
regression models predictive
robust models
shed new light
total serum globulin
vast amounts