BMJ  2008;336:250 (2 February), doi:10.1136/bmj.39470.632951.59

Observations

Open Letter

European regulatory agencies should employ full time statisticians

Sara Hughes, chair of PSI (professional UK body of statisticians in the pharmaceutical industry) and director of statistics, GlaxoSmithKline, Greenford UB6 0HE

chair@psiweb.org

The first 150 words of the full text of this article appear below.

We would like to draw attention to what we believe is a major deficiency in European regulatory agencies that are responsible for reviewing applications to market new medicines across the whole of the European Union. Only agencies in the UK, Germany, Sweden, and Austria employ several full time statisticians, and a few others employ a single statistician. Some agencies that have a major role in the European regulatory process, such as those of Italy and Spain, do not employ any full time statisticians—instead they rely on external consultants.

Statistics is central to the design of clinical trials and to the interpretation of their results. Key regulatory guidelines such as ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) E3, E9, and E10 carry this clear message, as do numerous disease specific, clinical guidelines from CHMP (Committee for Medicinal Products for Human Use). The clinical . . . [Full text of this article]


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Rapid Responses:

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Agreed!
Paolo Tomasi
bmj.com, 5 Feb 2008 [Full text]
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