‘The UK is open and ready to do the most challenging clinical trials … it’s the ideal place to do those trials.’
At an event for pharmaceutical organisations in Cambridge, Massachusetts earlier this week, Tom Nickalls, Deputy Consul General for the British Consulate in Boston, opened by encouraging companies doing cutting edge research to recognise why this is such a great place for health and social care research.
And like the title of the event (which is also the title of this blog), there is no arguing with the UK’s pivotal role in human clinical research. As I said in my own session, good co-ordination between regulators and our close links to the NHS mean the UK is uniquely able to support innovative approaches and complex trials.
We’re fast approaching the second anniversary of combined review for all new clinical trials of medicines and combined medicine and device trials. The joined up regulatory and ethics review has significantly shortened approval timelines. In some cases, this is now twice as fast as it was five years ago.
There has been much coverage of recent delays impacting our partner, the Medicines and Healthcare products Regulatory Agency (MHRA). Now thanks to its urgent action, more than 1,600 clinical trial applications and amendments have been assessed since mid-July, with all new applications since 1 September having their initial review within the 30-day timeline.
The HRA worked with the UK Research Ethics Service to respond to your feedback about the impact of the delays, and we took steps like giving early visibility of the outcome of the Research Ethics Committee (REC) review ahead of the formal combined outcome. In the coming months, we’ll keep working with the MHRA and others to implement the recommendations of the Lord O’Shaughnessy review; including new innovative and proportionate clinical trials legislation that will make it easier and faster for applicants to gain approvals and run studies in the UK.
In my session I also talked about our work with partners on what people-centred clinical research looks like. I talked about examples of work by the HRA and others in the UK to support decentralised trials, which are trials designed to work outside of research ‘centres’ and nearer to where participants live and work. I shared our principles for public involvement and our work to increase diversity in clinical trials. I was also able to share our new quality standards for participant information, so that everyone invited to take part in a study really understands what it will involve.
And that’s because whether you’re a Boston-based biotech or a university professor in Exeter, we’re here to support you to involve and include the right people in your study and to accelerate your research. It’s at the heart of our strategy, because together these things make it easy for you to do world-leading research here that people can trust.
Director of Approvals, Health Research Authority
Dr Janet Messer