The House

Improving the UK’s Clinical Research Environmen­t

- Dr Natalie White, PhD Executive Clinical Research Director UK & ROI, MSD natalie.white@msd.com

The Life Sciences Vision published in 2021 outlines the government’s ambitions for the sector over the next decade. It sets out the intention to make the UK the leading global centre for innovative research design and delivery across all types and phases of clinical trials, and to create a more efficient research environmen­t. This is critical for the UK life sciences ecosystem; embracing innovation is fundamenta­l to the long-term sustainabi­lity of the NHS, and to delivering better outcomes for patients in the UK and around the world. With a recession looming, the significan­t contributi­on of the life sciences sector to the UK economy is more important than ever, and the government has a key role to play in unlocking its growth potential.

State of Clinical Trials in the UK

A report published by the

ABPI demonstrat­ed a serious decline in industry clinical trials in the UK. Between 2017 and 2021, the number of trials initiated in the UK per year fell by 41% (Phase III down by 47%), the UK’s global ranking for late-stage clinical research fell from 4th in the world to 10th in Phase III trials, and patient access to industry clinical trials declined by 44%1. The Life Sciences Competitiv­eness Indicators published earlier this year reported that the UK tends to be slower than comparator countries in clinical trial set up2. These findings demonstrat­e a clear threat to the future of clinical research in the UK, but also present an opportunit­y for us to act now and get this right, to bring about the benefits of research to patients, the NHS, and the UK economy.

Rebuilding

Policy to support the delivery of clinical research is a vital component in ensuring the recovery of clinical trials in the UK. The Health & Care Bill includes a research mandate for Integrated Care Boards to deliver the UK clinical research vision, and developmen­t of the guidance and metrics to sit under this mandate is currently underway. This is an opportunit­y to drive the cultural change in the NHS as to how research is adopted as a part of core business, which will be critical for the implementa­tion of the Vision.

It is essential that industry is consulted in this process and considered a partner in the conversati­on, to ensure the guidance supports both commercial and non-commercial research. Commercial clinical research contribute­s significan­t economic benefits, generating an estimated income of £355 million for the NHS in England in 2018/20193. Assumption­s are often made about the needs of commercial sponsors, without them in the room. Getting this guidance wrong risks missing the once in a generation opportunit­y we have to see the change that is needed, to ensure the future of clinical research in the UK.

Looking forward

MSD has a significan­t footprint in the UK, with 139 clinical research studies currently underway and plans progressin­g for our £1billion London Discovery Centre. To sustain global boardroom sentiment about the UK’s leadership in clinical research, we need momentum and a doubled down focus on implementi­ng the Vision.

Slow and iterative changes to the UK clinical research environmen­t have been delivered over the last few years. Now is the time for more urgent and sustained changes, particular­ly in how the NHS is supported to deliver trials. Improving the commercial clinical research environmen­t would help attract further industry investment (delivering on the government’s plan for growth), contribute to health outcomes, and generate significan­t revenue for the NHS. To progress towards this ambition, we need a commitment from the government to engage with us now, so that we can be a true partner in solving the problems facing the sector.

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