EMIG welcomes DH funding for single approval system for clinical research

The announcement means a streamlining of the complex process of clinical research studies, making the setting up of such studies faster and easier by reducing bureaucracy and duplication.

Under the HRA plans there will now be just one application, one assessment and one approval for all research in the NHS in England.

EMIG R&D Director Mark Edwards said "EMIG welcomes the Government’s announcement on the simplification of the approvals process for clinical trials.

"Over the last few years, the UK has lost a significant degree of its competitiveness as a place to conduct clinical research, especially late stage, in large part because of the sheer complexity of the process and length of time it takes to gain the necessary ethics and NHS R&D approvals.

"The HRA, via its incorporation of the National Research Ethics Service (NRES), has dramatically improved the ethics review and approval process, and their plans for a new approvals systems addresses the key fundamental issues that have become a huge disincentive for commercial and non-commercial researchers alike and which consequently have undermined the competitiveness of the UK for clinical research for many years."

Clinical trials are vital to improving the delivery of better, safer human medicines and medical devices.

Today’s announcement means that funding will be dedicated to the delivery of research rather than wasted on complex, often duplicated and low-value-added processes, thereby benefitting researchers, funders, industry and patients alike.

It also has the potential to transform radically the attractiveness of the UK as a place to conduct clinical research and to put the UK ahead of the game in terms of being able to meet the requirements of the EU Clinical Trial legislation which needs to be implemented from 2016 in member states.