European regulatory agencies should employ full time statisticians to enable competent licensing and labelling decisions to be made, argue leading statisticians in an open letter to this week’s BMJ.
Sara Hughes, Chair of PSI, the professional UK body of statisticians in the pharmaceutical industry, and director of statistics at GlaxoSmithKline, together with 34 colleagues set out what they 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, they write. Some do not employ any full time statisticians – instead they rely on external consultants.
Yet, statistics is central to the design of clinical trials and to the interpretation of their results.
Unless the design and statistical analysis of a trial are appropriate, results cannot be considered reliable and no confidence can be placed in the subsequent clinical interpretation, they warn.
Another important role of regulatory agencies is to provide scientific advice and general guidance on statistical issues, they add. But, without permanent statisticians, agencies are at risk of giving incomplete advice.
In particular, they point out that innovation may be stifled if novel methods that are presented are methodologically sound but are disregarded because they are poorly understood by regulatory advisers.
They argue that statistical review should be conducted by those who are professionally expert in the area, not by medical assessors with some knowledge of statistics.
“We believe the current situation is unacceptable,” they say. “We call on the heads of the regulatory agencies in the EU that do not have full time statisticians in their organisations to rectify this as a matter of urgency.”