Increasingly complex and inconsistent clinical trial regulations are causing delays, raising costs and leading to a decline in the number of international trials conducted by academics for non-commerical purposes. In the E.U. alone, the number of applications for clinical trials fell by 25% between 2007 and 2011.
To boost medical research and help regulators overcome this problem, the Organization for Economic Co-operation and Development (OECD) is calling on its member governments to harmonize their clinical trial approval processes. The aim is to encourage international collaboration in clinical research and streamline procedures for conducting clinical trials.
Doing so will open up research in treatments that are driven by pressing public health needs but which currently offer few financial rewards for private companies. This is the case for rare diseases, such as cystic fibrosis, and medical conditions for which treatments are not profitable, such as some pediatric diseases, or pathologies in developing countries.
“This policy guidance is optimized for reducing the burden of trial oversight as far as possible; 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,” said Jacques Demotes, director of the European Clinical Research Infrastructure Network, who led the expert group that drafted the OECD recommendation.
Susan Shurin, deputy-director, U.S. National Heart, Lung and Blood Institute, said, “We have been struggling to conduct international trials addressing important health problems. This recommendation is a major achievement representing considerable effort by many scientists, physicians and regulators.”
A memorandum has been developed to explain the context and to facilitate the implementation of the principles contained in the recommendation, and is available here. More background material on the difficulties being encountered by the clinical research community in setting up international clinical trials is available in this report.