01.10.14
New EU rules to benefit NHS research
Since the introduction of the EU Clinical Trials Directive 10 years ago there has been a dramatic drop in the number of clinical trials with EU, and UK, involvement.
However, it is hoped this will soon change with the introduction of new EU law on clinical trials – which came into force on 16 June 2014.
But to allow sufficient time for the development and testing of the EU portal and database, which will support the regulation’s implementation, it will only be applied from 2016.
It is expected that the new rules will streamline the procedures to assess and authorise new clinical studies, removing duplications and reducing delays for launching clinical trials; introduce a lighter regulatory regime for trials conducted with medicines which are already authorised; simplify reporting requirements; and recognise that a trial can be led by more than one organisation, by formally introducing the concept of ‘co-sponsorship’
According to NHS Employers, this last point is of great importance for many NHS trusts which have co-sponsorship arrangements in place with their academic partners.
Elisabetta Zanon, director of the NHS European Office, said: “Research is a key component of a high-quality healthcare system and more than 99% of NHS trusts recruited patients for clinical studies in the last year. They directly contribute both to better patient care and early adoption of innovation.
She added that the existing EU rules have placed a huge bureaucratic burden on NHS organisations involved in clinical trials for a decade.
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