Stats
Two talks for PharmaIQ (September 19, 2006)
Category: Adverse events in clinical trials, Category: Research in
children
I may be giving a couple of talks for for
PharmaIQ,
a division of the International Quality & Productivity Center (IQPC).
The first has the title "Signal Detection Strategies for Paediatric Treatments" and the
following for an abstract:
Signal detection and pharmacovigilance are already highly regulated and
challenging fields, but once you factor in children as your patient group these
challenges become even greater. There are physiologic, ethical, and statistical
questions that you must consider for some (but not all) efforts in post marketing
surveillance.
Discuss openly with your peers the issues that complicate drug safety studies in
children and recognise when these issues apply and when they don't apply. Look at and
debate the merits of alternative data sources, research designs, and statistical
analyses to balance the sometimes conflicting needs of regulators, drug companies, and
ethical review boards.
I've started outlining some of my thoughts about this talk at
The second talk has the title "Control charts for continuous monitoring of the number
needed to harm." and the following for an abstract:
While most of the efforts in signal detection use newly developed data mining
algorithms that are both complex and computer intensive, there is still room in your
research arsenal for simpler approaches that have withstood the test of time, like the
statistical process control chart. By applying a straightforward data transformation,
you can use the control chart to monitor the Number Needed to Harm (NNH), an easily
interpreted measure of absolute risk.
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Identify those situations where simple control charts are preferable, but also
recognize their risks and limitations.
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Adapt different decision rules and alternate control chart formats to increase your
sensitivity for small but consistent shifts in risk.
-
Establish rational targets for the NNH that balance the benefits of a new drug
against its risks.
I was also asked to provide a biographical sketch. Here's what I wrote:
Steve Simon earned a Ph.D. in Statistics from the University of Iowa in 1982. He
currently works as a research biostatistician at Childrens Mercy Hospitals and Clinics
in Kansas City, MO. He has co-authored over 60 peer reviewed publications in a variety
of medical, scientific, and statistical journals. He recently published a book,
Statistical Evidence in Medical Trials, through Oxford University Press. He is the
architect and designer of StATS (Steve's Attempt to Teach Statistics) a widely cited web
site with over one thousand pages and has contributed material to two other prominent
web sites: Chance News and Wikipedia.
07/08/2008.
