OECD recommends global harmonisation of clinical trials rules
Guidance covers risk assessments and safety categorisation and other relevant issues
The Organisation for Economic Cooperation & Development (OECD) has recommended that its rich country members harmonise their clinical trials rules to promote international collaboration and help streamline regulations. It has issued principles for the trial rules that it wants its 34 member governments to adopt, which include many European Union countries, the US, Canada, Australia and Mexico.
The guidance covers risk assessments and categorisation; safety reporting; insurance and indemnification; ethics; documentation and other relevant issues.
The OECD is concerned about a falling number of medicine clinical trials, noting that numbers declined by 25% between 2007 and 2011. It has particular concerns regarding research into rare disease treatments, where immediate commercial returns are less evident, such as cystic fibrosis and paediatric conditions.
‘Increasingly complex and inconsistent clinical trials regulations are causing delays, raising costs and...a decline in the number of international trials conducted by academics for non-commercial purposes,’ the OECD said.
It claimed that harmonising clinical trials among OECD members would ‘open up research in treatments that are driven by pressing public health needs’.
The guidance drafting group leader, Professor Jacques Demotes, European Clinical Research Infrastructure Network Director, said: ‘This policy guidance is optimised for reducing the burden of trial oversight as far as possible.’