The proposals aim to simplify the rules for conducting clinical trials, which have been blamed for significantly reducing the numbers of trials undertaken, increasing costs and lengthening delays, and reflect a number of changes called for by the NHS European Office.
Key changes for the NHS
The comprehensive briefing details the key changes from an NHS perspective, which are:
- simpler authorisation procedure
- lighter regime for 'low-risk' clinical trials
- co-sponsorship will be possible
- simple safety reporting
- compensation for damages
- protection of participants and informed consent
- manufacturing and labelling of investigational medicinal products
- requirement of a master file
The proposals are the first revision of the EU Clinical Trials Directive and respond to wide criticism of the current regulatory framework voiced by many stakeholders from across Europe. The NHS European Office has been pressing for changes to the existing Directive for several years and welcomes many of changes, which reflect a number of amendments it has called for on behalf of the NHS.
Have your say
The European Office is seeking views on the proposed Regulation and its implications for conducting clinical research in the NHS, and will be establishing an expert group. If you would like to join this group, contribute your views, or discuss any aspect of the proposals, please contact email@example.com. Download Revising the Clinical Trials Directive.