It’s been an important week for clinical research, with two important documents published which should go a long way in helping to support clinical research as the UK leaves the EU.
Cancer Research UK has published a comprehensive report exploring the impact of Brexit on the future of clinical trials as a whole and cancer trials in particular in the UK and EU.
This comes shortly after the MHRA published an important notice regarding the Clinical Trials Regulation and its role in the UK during the implementation period under the terms set out in the draft Withdrawal Agreement.
The new Clinical Trials Regulation is a major step forward. It will enable a streamlined application process, harmonised assessment procedure, single portal for all EU clinical trials and simplified reporting procedures, including for multi-Member State trials. That’s why it’s good news that even if the new regulation does not come into force during the implementation period, the Government has confirmed UK law will remain aligned with parts of the CTR legislation. This will mean researchers conducting clinical trials can plan with greater certainty.
Today’s Cancer Research UK report details short and long-term issues which need to be addressed to support clinical research and patients in the UK. At the ABPI we support these findings.
In 2017, there were 823 applications for commercial clinical trials of medicines in UK. It is in the interests of patients and medicines development for us to find a way to continue to work together in clinical trials. The UK Government’s proposals for a new ‘Science and Innovation Pact’ with the EU say that collaboration enables researchers to work at greater scale than they can in their own countries and the proposals supports this spirit of future science collaboration.
Here is an analysis of some of the key points which are particularly relevant to pharmaceutical companies.
When patients take part in clinical trials, they are helping the patients of the future. We know from our own research this year that clinical research is important to people; two thirds (66 per cent) of British people said they are willing to allow the NHS to use their healthcare data for medical research. This important report sets out just why we must take great care to safeguard the future of clinical research for patients not just in the UK, but across the whole of the EU.