[StATS]: Two talks for PharmaIQ (created 2006-09-19)
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.
- *<U+FFFD>Identify those situations where simple control charts are preferable, but also recognize their risks and limitations.*
- 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.
This page was written by Steve Simon while working at Children’s Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children’s Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Children in research.
research](../category/ChildrenInResearch.html). for pages similar to this one at [Category: Children in with general help resources. You can also browse Children’s Mercy Hospital website. Need more information? I have a page reproducing it here as a service, as it is no longer available on the Hospital. Although I do not hold the copyright for this material, I am This page was written by Steve Simon while working at Children’s Mercy