Last month Lord O’Shaughnessy published his independent review into the UK’s commercial clinical trials landscape, and you may have seen him talking about it at the House of Lords Science and Technology Committee a couple of weeks ago.
The review was published alongside the government’s response, setting out actions to dramatically improve health research in the UK, focusing on improving the delivery of commercially funded clinical trials taking place here.
We welcomed the government’s response. Getting this right will lead to better evidence from research, that will improve access to safer and more effective treatments and save lives, and we have a key role to play in doing this.
During the committee hearing Lord O’Shaughnessy discussed how the number of clinical trials run by pharmaceutical companies in the UK has declined over recent years.
He also highlighted the recommendations in his review to help address this decline so that research can improve care faster.
The Lord O’Shaughnessy review and the Government’s response are really important because more research taking place in the UK means more opportunities for people in the UK to take part in clinical trials.
We’re here to make it easier to do research that people can trust, so we’re going to play a key role in making the Government’s commitments a reality.
We’re working with organisations across UK clinical research to drive this work forward. This includes:
- working with the Medicines and Healthcare products Regulatory Agency (MHRA), on achieving a 60-day turnaround time for regulatory approvals. Our Research Ethics review timelines are usually well within 60 days, so we are working with MHRA to make sure that our combined review achieves the 60-day target every time
- leading cross-sector work to establish a common approach to contacting patients about research. We know that people want to be offered opportunities to be involved in research relevant to them. Data in health records, databases and registries can help identify people to invite, but this personal data must be kept safe and secure. This work will help work out how we can make this possible to do in a way that people can trust
- supporting implementation of enhanced National Contract Value Review. To run trials in NHS sites, sponsors need to reach agreement on contractual terms of the trial delivery including costing. The NCVR was put in place to introduce a national streamlined approach to this service for commercial trials, making it easier to set up and conduct commercial research in the NHS
- working with NHS England, the Department of Health and Social Care and the National Institute for Health Care Research, to address delays in the set-up of research not caused by costing or contracting. Alongside the regulatory reviews, the sites where the research will take place need to put in place the arrangements to run the trial, so that they are ready to start when the study is approved. This process is inconsistent, as it depends on decisions made by individual NHS organisations and adds delays to the time for setting up a trial
- supporting efforts to collate and publish transparent performance data so that it is easier to see how well we are performing in the UK.
We’re delighted the O’Shaughnessy review and the government’s response recognise our important role in the UK research landscape and that they have confidence in us to build on work already underway.
They highlight some of the improvements we’ve already made as part of a UK-wide collaboration to improve clinical research and deliver a shared vision for clinical research delivery that will improve the lives of people across the UK.
This includes working with the MHRA on our combined review service, which saves researchers time on administrative procedures.
The Lord O’Shaughnessy recommendations build on great work that is already underway and, while they are focused on making the UK a better place to do commercial clinical trials, they will bring benefits for all clinical research.
We’re really excited to be working together with our partners to make the UK one of the easiest places in the world to do research people can trust.
We look forward to keeping you updated on our progress over the coming months.