Notice of a seminar at Glasgow University
Date Thursday 8 June 2006
Time 14:00-15:00
Place BOYD ORR : 412 (LT B)
(See building D1 on http://www.gla.ac.uk/general/maps/colourmap.pdf )
Exploratory Analysis of
Clinical Safety Data to Detect
Safety Signals
Frank E Harrell Jr, Professor and Chair , School of Medicine
Department of Biostatistics Vanderbilt University
Abstract
It is difficult to design a clinical study to provide sound inferences about
safety effects of drugs in addition to providing trustworthy evidence for
efficacy. Patient entry criteria and experimental design are targeted at
efficacy, and there are too many possible safety endpoints to be able to
control type I error while preserving power. Safety analysis tends to be
somewhat ad hoc and exploratory. But with the large quantity of safety data
acquired during clinical drug testing, safety data are rarely harvested to
their fullest potential. Also, decisions are sometimes made that result in
analyses that are somewhat arbitrary or that lose statistical efficiency. For
example, safety assessments can be too quick to rely on the proportion of
patients in each treatment group at each clinic visit who have a lab
measurement above two or three times the upper limit of normal.
Safety reports frequently fail to fully explore areas such as
• which types of patients are having AEs?
• what distortions in the tails of the distribution of lab values are taking
place?
• which AEs tend to occur in the same patient?
• how to clinical AEs correlate to continuous lab measurements at a
given time
• which AEs and lab abnormalities are uniquely related to treatment
assigned?
• do preclinically significant measurements at an earlier visit predict
AEs at a later visit?
Contact Stephen Senn [log in to unmask] if in need of further details
Stephen Senn
Professor of Statistics
Department of Statistics
15 University Gardens
<http://www.gla.ac.uk>University of Glasgow
G12 8QQ
Tel: +44 (0)141 330 5141
Fax: +44(0)141 330 4814
email [log in to unmask]
Private webpage: http://www.senns.demon.co.uk/home.html
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