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Statistical Reasoning in Pharmacovigilance

This module discusses the role of statistical reasoning and algorithms in pharmacovigilance, emphasizing their value in enhancing critical thinking rather than replacing it. While statistical algorithms can be useful in analyzing large datasets, they should not be relied upon without careful consideration of context and potential confounding factors. Disproportionality analysis is presented as a starting point for deeper investigation rather than a definitive conclusion.

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8 views1 page

Statistical Reasoning in Pharmacovigilance

This module discusses the role of statistical reasoning and algorithms in pharmacovigilance, emphasizing their value in enhancing critical thinking rather than replacing it. While statistical algorithms can be useful in analyzing large datasets, they should not be relied upon without careful consideration of context and potential confounding factors. Disproportionality analysis is presented as a starting point for deeper investigation rather than a definitive conclusion.

Uploaded by

anishabhatti20
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd

Module 5

Lesson 8

In this module we've discussed a place for statistical reasoning and algorithms in pharmacovigilance.
The power of statistical reasoning to challenge and enhance our thinking should benefit everyone,
but the value of statistical algorithms will really depend on your context. So if you're in a setting with
a very modest number of reports, you probably don't need statistical algorithms to find signals or
identify duplicates or anonymize your case narratives.

And even in a setting with very many reports, where these methods can be useful servants, they
would be terrible masters and we should never use them as an excuse not to think, but as an
inspiration to think even harder. Take disproportionality analysis for example. By now you'll
hopefully think of this not as a black box but as a search for deviations from a fairly simple baseline
model of independent reporting of the drug and the adverse event. And of course, there are many
reasons why we could see deviations from this model other than the drug actually causing this
adverse event. It may be for example that the drug and the adverse event tend to occur in the same
region of the world, or in the same time period or the same age group, and this is why they occur
together more often that we would expect. So, we shouldn't take measures of disproportionality at
face value or see them as an endpoint product, but really think of them as a starting point for further
careful thinking. Thank you for tuning in, I hope you've enjoyed this introduction to statistical
reasoning and algorithms in pharmacovigilance.

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