Rapid Responses to:

OBSERVATIONS:
Sara Hughes
European regulatory agencies should employ full time statisticians
BMJ 2008; 336: 250 [Full text]
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Rapid Responses published:

[Read Rapid Response] Agreed!
Paolo Tomasi   (5 February 2008)

Agreed! 5 February 2008
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Paolo Tomasi,
Scientific Administrator - EMEA
London E14 4HB

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Re: Agreed!

I work as a medical assessor at the European Medicines Agency, and I support the opinions expressed in the letter, on a personal level. It has to be said that statistical expertise does exist in regulatory agencies, and the fact that a person has a medical degree does not, as a rule, preclude knowledge of statistical principles and procedures. This is true even if a medical assessor may not be totally familiar with mathematical formulas and the inner workings of all the fancier and newer statistical techniques proposed: one does not need to be an engineer, with deep knowledge of internal combustion engines and electronic fuel injection parameters, to drive a car and judge its performance. However, it is true that having dedicated consultants for the toughest statistical problems would certainly benefit everyone involved: as an Italian writer once said, "there are lies, then there are big lies, and then there are statistics".

Paolo Tomasi, M.D. Ph.D. European Medicines Agency London

Disclaimer: all opinions herein are personal and do not involve my employer.

Competing interests: None declared