Last week the European Commission formally adopted a plan to revise the rules that govern clinical trials in Europe in a bid to simplify the authorisation process and halt the decline in the amount of research carried out in European Union (EU) countries.
The move was backed by industry groups - like ACRO, EFPIA and UK groups ABPI and BIA – and CROs including Parexel, which told Outsouring-pharma.com that the current regulations have never quite achieved what they set out to do.
“The aim of the Clinical Trial (CT) Directive was to introduce harmonisation in the EU/EEA however that objective was never fully achieved due to difference in transposition of the directive as well as of application of associated guidelines.”
And while Parexel did not lay all the blame for the decline in Europe’s trials sector on the current rules – citing ‘national factors outside the scope of the legislation’ as having an impact – it welcomed the plan to make them simpler.
“The nature of the current directive alone has not deterred commercial sponsors from conducting trials in the EU/EEA nevertheless a more streamlined process would be beneficial.
In particular Parexel is in favour of plans for risk-based assessment, explaining that: “The concept of proportionality will simplify the authorisation and monitoring of low intervention clinical trials. We look forward to the publication of the proposed delegated acts which will add further details to the procedures outlined thus far.
Parexel was less positive about the proposal to give individual member states the final say on ethical issues related to clinical trials rather than a centralised authority, questioning how such as system will operate.
“While this is an intriguing approach the procedure for its delivery is not prescribed. As such it is essential that each member state establishes an effective mechanism for collaboration of the various parties by 2016.”
Transition too long?
Parexel also commented on the timeline for the proposed revisions, suggesting that: “The implementation date of 2016 is longer than expected and indeed is longer than that for the CT Directive, even allowing for national transposition of the latter.
“The proposed transition period could result in some clinical trials still operating under the CT directive until 2019.”
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