In April 2014, the European Commission adopted the new Regulation EU No 536/2014, intended to streamline the clinical trial approval process by simplifying the authorisation procedure, allowing a single application to be sufficient across several Member States, strengthening transparency and helping to make the EU more attractive for clinical research.
The new regulation is set to come into force at the end of 2017, and according to Martine Dehlinger-Kremer, global VP of medical and regulatory affairs at CRO SynteractHCR, it will be “one of most important changes in the field of clinical trials in the last decade.”
“Not only does it affect the clinical trial application process, but is also impacts further aspects of clinical research,” she told Outsourcing-Pharma ahead of a presentation at tomorrow’s Partnership in Clinical Trials (PCT) in Hamburg, Germany.
These include permitting co-sponsorship of trials, allowing the sponsor to determine the extent and nature of monitoring based on the characteristics of the clinical trial, and increasing transparency through a publicly accessible EU trial database.
Reverse the downward trend
“The time and costs of conducting clinical trials in the EU have grown significantly, and there is little cooperation among the Member States and no pooling of expert knowledge,” Dehlinger-Kremer said, adding that between2007 and 2011, the number of clinical trial applications fell by 25%.
“The new Directive, which is being revised to become a Regulation, requires no national interpretation and will create standardization while still leaving some room for national laws.
“Europe really needed one common legislation in order to remain attractive for clinical research.”
While this is good news for Europe’s clinical trial sector, Dehlinger-Kremer warned that contract research organisations (CROs) and sponsors must be prepared for these changes and the greater centralisation of the work in relation to the clinical trial applications and maintenance which it is expected to create.
“Both CROs and Sponsors need to get prepared for the short timelines, as not meeting the deadlines will have immediate consequences on the clinical trial timelines.”
Furthermore, enough resources will need to be available and CROs and sponsors will need to establish solid planning for each trial.
“The new Regulation will allow better planning of trials, which was quite challenging under the Clinical Trials Directive given the differences in timelines and procedures in the various countries.”