Senior policy officials in Europe are battling inconsistent and complex clinical trial regulations that are causing delays and raising costs by advancing a new framework to get global regulators on the same page.

The Organization for Economic Co-operation and Development is calling on regulators within its member governments to streamline procedures for conducting clinical trials in order to boost medical research and encourage international collaboration in clinical research. Harmonizing regulations, they hope, will make it easier for researchers to test treatments to address pressing public health needs which currently offer few financial rewards, including rare diseases.

The OECD’s Committee for Scientific and Technological Policy is recommending its members, including the United States, adapt their national regulations and procedures to incorporate a risk-based methodology for the oversight and management of clinical trials. The committee will monitor their implementation and report back to the OECD within four years.

“We have been struggling to conduct international trials addressing important health problems,” said Susan Shurin, Deputy Director of the U.S. National Heart, Lung and Blood Institute. “This recommendation is a major achievement representing considerable effort by many scientists, physicians and regulators.”

Cross-border trials involve approximately two-thirds of all subjects enrolled in a clinical trial. But the number of international trials conducted by academics for non-commercial purposes is declining, says the OECD, which drew up the recommendations for its members. In the European Union alone, the number of applications for clinical trials fell by 25 percent between 2007 and 2011, the group says. Yet, despite regional and international initiatives intended to smooth out the process, “increased administrative complexity of the system has often constituted a serious impediment for many of the stakeholders involved,” according to the OECD’s Committee for Scientific and Technological Policy.

“This policy guidance is optimized for reducing the burden of trial oversight as far as possible,” says Jacques Demotes, director of the European Clinical Research Infrastructure Network, who led the expert group that drafted the recommendation. “It should greatly facilitate the current discussion on the new European regulations, and will make it much easier to run independent clinical trials in Europe.”