Healthy Skepticism Library item: 12688

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Publication type: Journal Article

Hughes S.
Open Letter: European regulatory agencies should employ full time statisticians
BMJ 2008 Feb 2; 336:(7638):250
http://www.bmj.com/cgi/content/extract/336/7638/250?etoc

Abstract:

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 . . .