In a reflection paper, the EMEA has attempted to analyse the various factors that could be important in gauging whether additional clinical trials would need to be undertaken within the EU in support of an MAA.
The factors that need to be taken into account come under three main themes: medical practice, disease definition and study population.
For medical practice there may be relevant differences in co-medications and invasive procedures that need to be identified, says the paper. Meanwhile, medical conditions may be defined differently throughout the world, potentially introducing biases in the evaluation of the results.
And if the study population differs between geographical areas, this will most likely affect the applicability of the results, it notes.
In addition to these three factors, life style - including medical and social environment, genetic factors and genotype pathogen strain - was also found to be of importance
Drug development increasingly global
“Drug development is increasingly global and an increasing percentage of pivotal studies submitted to the European regulatory authorities are conducted outside the EU and the US,” according to the document, which is available for download here.
It is well recognised that drug trials are increasingly being carried out in emerging markets such as Asia, Latin America and Eastern Europe. The trend is being driven by greater availability of willing trial participants in these countries – particularly those who have not been exposed to pharmacologic interventions in the past – as well as lower costs and the increasing financial importance of these markets.
“There is a need to understand the differences and concerns that may arise in the extrapolation of study results to the EU population,” the EMEA continues.
The International Conference on Harmonization (ICH), which attempts to bring regulatory requirements for medicines into line around the world, has a guideline (ICH E5) which already identifies extrinsic factors to be considered in for evaluating the impact of ethnic factors upon the efficacy or safety of a product
The agency has also published a strategy paper on the topic of acceptance of clinical trials performed in third countries.