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Dr Ryan O'Shaughnessy is a Senior Lecturer in the Centre for Cell Biology and Cutaneous Research. He leads a research programme focused on understanding molecular mechanisms of skin barrier function and through these insights, developing new therapies for diseases of skin barrier function, with particular emphasis on the ichthyoses, eczema and ...
Discover Dr Terence C. O'Shaughnessy, a specialist in General internal medicine and Respiratory medicine, practicing in the E1, E11 and E2 area. Visit the profile page to learn more about qualifications, read patient reviews, and book an appointment online easily.
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Nov 22, 2023 · The government has published its full response to Lord O’Shaughnessy’s independent review into commercial clinical trials in the UK. The response sets out plans to make the UK one of the best places in the world for clinical trials, by implementing all of the recommendations in the review.
He oversees a mission-driven $3.2 billion health system in Long Island, encompassing six acute care hospitals, three nursing homes, home health services, hospice, a network of physician practices and more than 16,000 employees.
- Ministerial foreword
- Executive summary
- Governance
- 1. Progress since the initial response in May 2023
- 2. Our next steps
We welcome the areas highlighted by Lord O’Shaughnessy in his review of commercial trials, which has brought a fresh perspective and helped us to prioritise key areas of the ongoing work to implement the vision set out in Saving and Improving Lives: The Future of UK Clinical Research Delivery.
The actions we are taking now to address the recommendations of the review will provide benefits for patients and the NHS across the UK, improve the environment for all types of clinical research and drive forward improvements urgently to maintain our place as one of the most attractive places in the world to conduct industry clinical trials. Our actions are supporting our fantastic life sciences sector, bringing investments into the UK and helping to build the economy. By delivering improvements across the whole clinical research pathway from early translation to late phase trials, we will ensure more people have access to innovative clinical trials that are relevant to them, and ultimately deliver better prevention, treatment and care for all.
Since March 2021, we have taken bold action to implement our vision and recover from the impact of the pandemic on non-COVID-19 research. The strengths we demonstrated during the pandemic had a worldwide impact. We proved our ability to deliver trials that were not possible anywhere else in the world at such scale and speed. These achievements were possible due to the integration of our research delivery system within our healthcare system, as well as close working between the industry and the UK’s clinical research infrastructure in the NHS and academia to deliver research in new and innovative ways. While the strengths of our system made our research response to COVID-19 possible, the system is also complex, and solutions to streamline processes and reduce bureaucracy can be difficult to achieve.
The 5 headline commitments made in the initial response to the O’Shaughnessy review drove forward existing efforts to make progress on these long-standing issues. Through the focused and dedicated efforts of people working across the whole UK research system we have made significant leaps forward in the last 6 months:
•backlogs in research approval applications have been cleared by the Medicines and Healthcare Products Regulatory Agency (MHRA) and they have recently introduced a new notification scheme for phase 4 and low-risk phase 3 clinical trials
•barriers to the acceptance of nationally agreed costs have been removed and an approach which both increases transparency for industry and ensures full cost recovery by the NHS has been implemented
In March 2021, we published our bold and ambitious 10 year vision Saving and Improving Lives: The Future of UK Clinical Research Delivery. This was followed by the publication of implementation plan for 2021 to 2022 and implementation plan for 2022 to 2025 which set out the steps we would take to progress the vision in 2021 to 2022.
Lord O’Shaughnessy’s review of commercial clinical trials, commissioned in February 2023 and published in May 2023, identified key challenges in conducting commercial clinical trials in the UK and offered recommendations on how addressing them could help the life sciences sector unlock UK health, growth and investment opportunities. The initial UK government response, published alongside the review, welcomed all recommendations from the review in principle, and made 5 headline commitments backed by up to £121 million. This is complemented by £10 million funding for the Medicines and Healthcare products Regulatory Agency (MHRA) to fast-track patient access to cutting-edge medical products and £175 million funding for health data infrastructure in England through the Data for Research and Development Programme.
This report sets out our response in full. It provides an update on progress made against the initial commitments and provides a prioritised response on both the remaining recommendations and the existing programme of work announced in our previous implementation plans. This document updates and supersedes our previous plans and provides renewed focus to ensure we make the progress necessary to ensure we are a global leader in the delivery of life sciences research while also ensuring continued progress towards our 10-year vision.
We have made significant progress against all 5 headline commitments and this report provides a detailed update on each. We have also completed work to successfully recover the delivery of clinical research in the NHS and have reversed the drop in commercial clinical research identified by Lord O’Shaughnessy in his review. UK performance in commercial clinical research has now exceeded pre-pandemic levels with the numbers of studies, levels of recruitment and delivery to time and target, all delivering at a higher rate than previously seen.
Figure 1: open studies delivering to time and target by month (in England)
Figure 1 shows on track as per CPMS or validated ‘on track’ by sponsor studies increasing from 26% in September 2022 to 80% in October 2023. It shows off track studies decreasing, from 72% in September 2022 to 20% in October 2023.
While many actions are already underway, in publishing this response we can fully move forward with the operational delivery and monitoring of the commitments we have made. Overall delivery of the plan sits with DHSC and the devolved administrations. However, this plan is system-wide and therefore there are many accountable partners who have responsibility for the performance and delivery of specific commitments including NHS England (NHSE) and other relevant arm’s length bodies. For example, the MHRA and Health Research Authority (HRA) are accountable for performance against the 60-day approval turnaround key performance indicators and NHS trusts are contracted by commercial companies to successfully recruit to and deliver trials.
Reporting of the key performance metrics in this plan and co-ordination of delivery of the will be overseen through the UK Clinical Research Recovery Resilience and Growth (RRG) programme, organised by DHSC, with reporting to the Life Sciences Vision Delivery Board and Life Sciences Council (overseen jointly with the Department of Science, Innovation and Technology (DSIT)) and other groups with responsibility for health research such as the Office for Strategic Coordination of Health Research (OSCHR). The programme will monitor and drive progress towards the commitments in this plan, to ensure they are having the intended benefits on the delivery of commercial clinical research and across the whole clinical research ecosystem. Where components of the action plan are specifically linked to missions in the Life Sciences Vision, then governance will follow existing reporting lines, in addition to the overarching oversight, managed through the Office for Life Sciences.
As an immediate first step towards the response to the O’Shaughnessy review, the UK government made 5 headline commitments backed by up to £121 million, together with a foundational action to develop SMART (specific, measurable, achievable, relevant and time-bound) objectives for all the ambitions in the clinical research vision, Saving and Improving Lives: The Future of UK Clinical Research Delivery, (the vision). These headline commitments remain the core priorities in our overall response to improve the delivery of commercial clinical trials in the UK - ensuring more people across the UK can access new treatments being assessed in clinical trials more quickly.
We have made significant progress in the first 6 months of implementation and, in addition, completed work to recover clinical research performance to pre-pandemic levels, announced the launch of a new Research Delivery Network for England, and implemented a new MHRA notification scheme for clinical trial application approvals. We will continue to build on this, at pace, to increase the speed and predictability of commercial research further while ensuring the continued success of non-commercial research. In the section below, we update the progress and actions against the recommendations prioritised in the initial response.
Over the next 2 years, we will continue to implement in full the 5 headline commitments announced in May 2023, make progress in tackling all the problem statements identified by Lord O’Shaughnessy, and continue work underway to improve the UK environment for all types of clinical research. We have reprioritised previously published implementation plans considering Lord O’Shaughnessy’s recommendations and feedback from a broad range of stakeholders, and this plan supersedes and replaces them while not losing the ambition and vision set out in Saving and Improving Lives: The Future of UK Clinical Research Delivery.
In the following section we set out SMART metrics in greater detail for all the ambitions set out in Saving and Improving Lives: The Future of UK Clinical Research Delivery, addressing recommendation 1 of the O’Shaughnessy review.
Check Dr. O'Shaughnessy's profile to see which insurance they accept. Where is Dr. O'Shaughnessy's office located? Dr. O'Shaughnessy's office is located at 2011 Murphy Ave, Nashville, TN.
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O'Shaughnessy is now a senior partner at Newmarket Strategy, a medical consultancy which he co-founded in 2021. O'Shaughnessy was born on 26 March 1976 in Taplow, Buckinghamshire, England. [2] He was educated in Berkshire at Claires Court School then Wellington College.
