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Paolo Tomasi, Scientific Administrator - EMEA London E14 4HB
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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 |
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