EMEA Reflection Paper on the Extrapolation of Results from Clinical Studies published

The EMEA has published a Reflection Paper on the Extrapolation of Results from Clinical Studies conducted outside the EU to the EU-Population, which will come into effect on 01 May 2010.

Pharmaceutical and clinical development activities are increasing global and more and more studies are conducted outside the EU for several reasons. The various study results may be extrapolated. However this might lead to concerns mainly regarding to:

  • Medical practice (e.g. differences in co-medications and invasive procedures, standard of care)
  • Disease definition (heterogeneous medical conditions may be defined differently or different traditions concerning the medicalisation of some conditions are existing)
  • Study population (e.g. differences in life style, social environment, genetic factors, genotype pathogen strain)

The reflection paper discusses the issues which may influence the applicability of foreign data on an EU setting. These factors are also identified in the ICH E5, which highlights the importance of this guideline in the planning of worldwide clinical studies. The current paper identifies specific issues based on experience specific to the EU population and should be regarded as a reinforcement of the ICH Q5.

The reflection paper does highlight examples of mainly extrinsic, but also intrinsic factors that may complicate the extrapolation of results from clinical studies between geographical areas worldwide, as well within the EU population.

Summarised by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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