How to Make the Most of the EU's New Clinical Trial Environment
By: Mateo Guiscafré, PhD | November 06, 2014
For years, the European biopharmaceutical market has been viewed as an alluring but risky destination for biopharmaceutical companies interested in conducting global clinical trials. The fragmented regulatory environment, along with cultural and language barriers, made it a challenging and often costly environment in which to run research initiatives. But that will soon change.
In the spring of 2014, the European Parliament updated its directive on clinical trials with a new regulation that is expected to streamline the approval process for studies across the EU, harmonize regulation of trials, and increase transparency around results.
Oversight and approval of clinical trials will still fall to individual country regulators. However, the European Medicines Agency (EMA) will provide overarching regulatory guidance, along with new technology, expert support, and supervision on enforcement of the new directive. Once fully implemented, in 2016, this new directive could dramatically improve the value-proposition of running clinical trials in all 28 EU countries.
Better, faster, broader appeal
On the front end of the clinical trial planning and management process, this updated directive will speed trial timelines by eliminating much of the regulatory red tape, and allow teams to submit a single trial application and reports for the entire region via an electronic EU portal. It will also enable companies to site trials in the best possible location based on cost, and access to patients and staff -- without having to factor complicated local regulatory issues into the equation. And one of the most compelling aspects of the updated directive is the impact it will have on patient recruitment and education, which can now cross borders.
On the back end of the clinical trial process, the updated directive will broaden the value of clinical trial data, by allowing the results of a trial conducted in one country to now act as a reference for the entire region.
These changes won’t just benefit biopharma companies. The harmonization efforts remove much of the complexity from the EU biopharma industry that has slowed its ability to be competitive. Companies that have long been wary of the obstacles of running trials in the regions will no longer have to worry. This should bolster competitiveness and innovation across the region, and facilitate faster and more efficient development of new medicines for patients in the EU and elsewhere.
Global biopharma companies have a unique opportunity to use this transition period to rethink their approach to running clinical trials in the EU. Once fully implemented, the updated directive and resulting harmonization will impact critical decision and planning steps across the clinical trial process, from where to locate trials, to projecting costs and schedules, and identifying the most effective recruitment strategies for patients and workforce. As we think about how to approach this new EU clinical trial environment, it may be helpful to look at US trial strategies for planning and recruitment, as the two regions will now be more similarly aligned.
The new legislation promises to open up a new era for the conduct of trials, ensuring that clinical research will remain a powerful economic driver across EU member nations for years to come. Companies that proactively plan for this new environment will be able to take full advantage of the time and costs savings as soon as they are achievable, which will help them gain an advantage over competitors who take a reactive approach to these changes.