Intended for healthcare professionals

Observations Open Letter

European regulatory agencies should employ full time statisticians

BMJ 2008; 336 doi: (Published 31 January 2008) Cite this as: BMJ 2008;336:250
  1. Sara Hughes, chair of PSI (professional UK body of statisticians in the pharmaceutical industry) and director of statistics, GlaxoSmithKline, Greenford UB6 0HE
  1. chair{at}

    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 trial component of regulatory submissions can be made up of the accumulated data from several thousand patients enrolled in several clinical trials. Evaluation of the data requires consideration of the impact of complex statistical issues relating to design of the trial and analysis of the data, such as bias in trial design, use of multiple end …

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