Applied Clinical Trials
While approved in 2014, Europe's new regulation governing clinical studies is set to take effect in May-leaving interested parties only six more months to prepare for its arrival.
The European Union (EU) Regulation 536/2014 was approved by the European Parliament in April 2014, replacing the decade-old Directive 2001/20/EC, commonly referred to as the Clinical Trials Directive. While the new law was approved in 2014, it does not apply until, at the earliest, May 28, 2016-leaving interested parties still with almost six months to prepare for its arrival.
The benefits associated with the new Regulation include a single submission portal, standardized content of clinical trial applications, information about subject protection and informed consent, more stringent requirements for reporting trial progress, and greater transparency about clinical trials. The operational database for clinical trials and a portal for submissions was planned to be set up by the European Medicines Agency (EMA) by January. The portal must have six months of functionality before the regulation comes into effect, thus determining the earliest date as May 28.
However, even with these benefits, the past Directive is linked with the uncertainty of the future regulation, as came to light in a survey conducted last summer. Applied Clinical Trials and SCORR Marketing surveyed our audience on global regulatory issues, with the new Directive central to the questionnaire. In the survey, we asked if Directive 2001/20/EC has impacted your organization. The majority-57%-said yes. When asked how, the respondents said increased costs, followed by increased bureaucracy, at 54% and 46%, respectively. Our EU expert and Brussels correspondent Peter O’Donnell noted, “The nature of the impact is in line with general concerns expressed by the clinical trial community during and since the Directive’s genesis: the increased bureaucracy is nearly as inimical as the increased cost.”
There has been concern that there is a marked decline in clinical trials placed in Western Europe, which is a direct result of the Directive 2001/20/EC. However, when asked if the Directive has made Europe a less attractive place to conduct trials, 59% said no and 41% yes. The EU Regulation 536/2014 will be applied fully in all Member States, with no need for separate national legislation, with the hope the result will be uniform application throughout the EU.
Survey respondents were divided on the potential positive benefits of the new Regulation. Fifty-one percent believe the measure will go far enough to address some of the obstacles to doing research in Europe, while 49% are not convinced.
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