With a new Regulation on clinical trials coming into full effect in the European Union (EU) by October 2018, U.S.-based sponsors can expect a greater degree of harmonization across the countries in the EU, especially in terms of review, approval, and reporting, says Jo Burmester, BSc, director of global operations with PharmaSchool Ltd.
“There will be a central portal for all submissions and reports, and there will be a new approval process for Clinical Trial Authorizations [CTAs], which will include centralized review of applications by all Member States (countries) involved,” adds Burmester, who led a half-day workshop on “Hands Across the Water: A Comparison of Clinical Trials in the EU and U.S.” today at the ACRP 2017 Meeting & Expo in Seattle, WA.
The challenges to running multinational trials involving EU sites “will be similar, in that you will still be dealing with a large number of independent countries with different languages, cultures, and regulatory set ups,” Burmester explains. However, with the new Regulation (formally known as the “new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”), there will be an increase in the level of reporting required.
For example, Burmester says, “serious breaches of the Regulation or the protocol will have to be reported within seven days, as is the case already in the U.K. The harmonized central review and reporting should make life much easier in the long run, though.”
More details about the EU Regulation can be found in a peer-reviewed article by Yves Geysels, PhD, Christopher A. Bamford, PhD, and Richard H. Corr on “The New European Regulation for Clinical Trials” from the February 2017 issue of Clinical Researcher.
Author: Gary Cramer