As participation in clinical research falls, Alison Culpan Director of the ABPI in Scotland looks at why Scotland should be investing in this multi-million pound activity.
Phase 3 clinical trials, in large enough populations to provide solid evidence for regulators, represent multi-million pound inward investments to Scotland and life-saving possibilities for patients.
The NHS gets paid for each patient it recruits to a trial and also saves money because the cost of the medicines for all those enrolled, whether getting the new treatment or the ‘standard of care’ medicine, is met by the sponsoring company.
The brightest and best clinicians are often attracted to the centres where they can have an active role in research. Meanwhile, patients receive a higher level of observation during a trial alongside the obvious benefit if the treatment is right for them.
However, when the Fraser of Allander Institute at Strathclyde University this year published its updated assessment of the economic contribution of the pharmaceutical sector in Scotland, the authors expressed concern that clinical trials activity, a key plank of the Scottish government’s Export Growth Plan “has been struggling for a number of years in the UK”.
According to NHS Research Scotland, 40,000 people took part in clinical research trials in the year 2021-22, yet there were over 35,000 new cases of cancer alone in Scotland in that same period.
Many cancer clinical trials took place elsewhere and our own research shows a 44 per cent reduction in the number of people enrolled into UK research sponsored by industry in 2021-2022 compared with 2017-18.
Fewer trials were initiated, and the UK slipped from fourth in the world to tenth, as global pharmaceutical companies chose other countries.
We need to address and reverse this drop down the ranks immediately and, although I’m sure Scotland will eventually get the medicines currently being trialled elsewhere, we will have missed an enormous opportunity.
In response to the argument that the NHS is overwhelmed and its core business is treating patients not doing research, I agree with a leading Scottish professor of oncology who pointed out in a recent report on genomic medicine: “If you go back and look at the founding document for the NHS in 1947, written into that is the expectation that the NHS will be a place in which research and development can and should be done”.
Furthermore, as detailed above, clinical trials pay the NHS for recruiting patients while saving it further money by covering the costs of medicine for all involved, and on the most caring level, patients have the reassurance of a higher level of observation and the possibility of a better outcome.
Last month, an independent review of clinical trials across the UK led by Lord James O’Shaughnessy, commissioned by the UK government on behalf of all four nations, made a series of 27 recommendations to deliver significant and sustained growth in the level of clinical trial activity.
Recommendation 7 calls for the doubling of recruitment to commercial clinical trials within the next two years, and a further doubling by 2027.
We would estimate that increasing industry clinical research’s share of total recruitment from 2.2 per cent to 8 per cent between 2024 and 2029 would generate £3.5 billion in revenue across the UK, £678 million in cost savings for the NHS, and create £14.9 billion gross value added for the UK economy.
Many of the O’Shaughnessy recommendations cover devolved issues – such as easing planning processes for new pharmaceutical sites and incentivising GPs with payments for each patient enrolled in a trial – so fall to the Scottish government to deliver.
On the day the report was published, Health Secretary Michael Matheson MSP acknowledged the fundamental role of attracting and delivering clinical research trials in the recovery and reform of the NHS in Scotland – and the part trials can play in improving patient outcomes.
The job of considering each O’Shaughnessy recommendation for Scotland is now in the hands of Scotland’s Chief Scientist for Health, Professor Dame Anna Dominiczak.
That task may be Dame Anna’s, but achieving the potential of clinical trials for Scotland’s patients, NHS, universities and economy, will be down to all of us. l
About the Association of the British Pharmaceutical Industry (ABPI)
The ABPI exists to make the UK the best place in the world to research, develop and use new medicines and vaccines. We represent companies of all sizes who invest in discovering the medicines of the future.
Our members supply cutting edge treatments that improve and save the lives of millions of people. We work in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines.
Every day, we partner with organisations in the life sciences community and beyond to transform lives across Scotland and the UK.