THE CAMBRIDGE STATISTICS DISCUSSION GROUP
Tuesday 3rd February 2009 7:15 for 7:45
Department of Applied Mathematics and Theoretical Physics,
Centre for Mathematical Sciences,
Wilberforce Road,
Cambridge
Meta-analysis of clinical trials, particularly of rare adverse events.
Peter Lane
Research Statistics Unit, GlaxoSmithKline
Abstract:
Meta-analyses are increasingly being used to summarize information
across clinical trials, often to publicize good or bad news. Public
access to trial results on the Internet has made it especially easy to
generate such meta-analyses, particularly of safety issues. Once
the hurdles of acquiring and selecting data have been cleared, the task
of analysis with some given technique is only too easy. The results can
be strongly influenced, however, by the choice of technique and the
approach to combining information when the operating details vary across
individual trials. The analysis of rare events, particularly safety
events, is prone to disagreement and misunderstanding. I will look
specifically at the meta-analysis of a binary response, illustrated
by publicly available data from the high-profile analysis in 2007 of
Avandia with respect to cardiovascular safety. This raised issues
including the choice of summary statistic to employ, the combination
of trials with different control treatments, and the handling of trials
with no events. And lurking in the background was the ever-present
danger of being misled by Simpson's Paradox.
Speaker:
Peter Lane is director of consultancy and training in the Research
Statistics Unit in GlaxoSmithKline. He is based in Harlow, where he
has worked for nine years since moving to the pharmaceutical
industry. He is responsible for the consultancy and training carried
out by the ten members of the Unit, who provide statistical advice
across the company, though predominantly in support of clinical
drug-development. His recent projects include several investigations
of meta-analysis, particularly the recent high-profile ones involving
GSK drugs; he has also been part of a working group in the main
statistical division of GSK aimed at encouraging more effective use
of graphics; and he is on a cross-company expert team trying to
persuade the Food and Drug Administration to move away from the use
of "last observation carried forward" in longitudinal trials. His
main interests are the application of generalized linear and
nonlinear models, statistical graphics, model checking, missing data,
and sample-size estimation. These interests were developed in his
previous existence in the Statistics Department at Rothamsted, where
he worked for 25 years as a consultant statistician, primarily with
soil scientists, and a developer of the GenStat statistical system.
This appointment followed directly after a Diploma in Mathematical
Statistics and a degree in Mathematics at Cambridge University.
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