The OECD is urging its member governments to harmonise their clinical trial approval processes, citing a decline in the pharmaceutical sector in the EU, where the number of applications for clinical trials fell 25% between 2007 and 2011.
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-commercial purposes, the Organisation for Economic Co-operation and Development warned yesterday (25 February).
Many scientists say that in recent years clinical research has moved to non-European countries because some nations are less strict in their oversight of trials. The European Commission proposed a revamp of the Clinical Trials Directive to make it easier for companies to carry out research and bring new therapies to the market faster.
To boost medical research and help regulators overcome this problem, the OECD, the global economic policy forum, urges member states to streamline procedures for conducting clinical trials in new recommendations.
"This policy guidance is optimised 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.
The OECD recommends, among other things, that member states adapt their national regulations and procedures to incorporate a risk-based methodology for the oversight and management of clinical trials.
Following the recommendation would, according to the OECD, 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.
Susan Shurin, deputy director of the US National Heart, Lung and Blood Institute, said there has been a struggle to conduct international trials addressing important health problems.
"This recommendation is a major achievement representing considerable effort by many scientists, physicians and regulators,” she said.
The European Commission proposed new rules in July 2012 to make it easier for drug companies and researchers to carry out cross-border clinical trials, in a bid to cut costs and red tape.
The EU's Clinical Trials Directive was implemented in 2004 with a view to improving research standards and protecting patients.
But those rules have been criticised by researchers who say costs and red tape has increased without bringing any major benefit to patients, researchers or industry
- 2013: European Parliament and Council to examine draft new rules on clinical trials
- Commission: Clinical trials
- Parliament: Legislative file: Clinical trials on medicinal products for human use
- Organisation for Economic Co-operation and Development (OECD): Recommendation of the Council on the Governance of Clinical Trials (25 Feb. 2013)
- EURACTIV Slovakia: OECD má rady pre klinický výskum