Single sponsor set to remain the rule for EU clinical trials
EC also calls for more precise rules for drafting application dossiers
The European Commission (EC) favours more closely harmonising EU clinical trials rules, which at present differ among the 27 member states. This is in spite of the EU Clinical Trials Directive, which is now under review.
In a consultation paper, ahead of formal reform proposals expected in 2012, the EC outlined the benefits of harmonising the rules.
‘The requirements set out in the…Directive are applied differently in the different member states,’ the paper said.
‘While the broad concepts are identical, divergent and conflicting points of view can emerge when dealing with the details of the request for authorisation.’
Assessments are also carried out nationally, which ‘creates unnecessary administrative costs’.
This has sparked calls for the Directive not to apply to academic and more non-interventional trials (those staged within existing market authorisations).
The EC said a better approach would be a detailed harmonisation of trials within the EU, which would apply to all clinical trials. This would help solve problems associated with the current rule insisting that one company remains responsible for clinical trials, even when staged in a number of countries.
The EC had admitted that the ‘single sponsor’ rule ‘renders multinational clinical trials more onerous’. However, the main problem seems to stem from the divergent requirements among member states.
‘If these requirements were truly harmonised the question of the ‘responsibility’ for a clinical trial may be less critical,’ the EC said.
The EC also calls for more precise and risk-adapted rules for drafting application dossiers and safety reporting and for clarifying definitions of investigational medicinal product and establishing rules for assessing auxiliary medicinal products.