Giving hope to those affected
by secondary breast cancer
Research. Support. Education.
Giving hope to those affected
by secondary breast cancer
An independent review, commissioned by the UK government and led by Lord O’Shaughnessy, has recently been published with many recommendations on how to tackle the key challenges in delivering commercial clinical trials and how the environment for commercial clinical trials can be improved in the UK.
Although the UK has an illustrious track record in the area of clinical trials, both historically and with recent successes, such as with the COVID-19 vaccine and therapeutic COVID drug trials, in recent years the UK has started to fall behind in commercial clinical trial activity.
The number of participants in commercial research, supported by the National Institute for Health and Care Research (NIHR), has substantially declined from over 50,000 patients in 2017-2018 to just over 28,000 in 2021-2022, which was the lowest number of patients recruited in the last 7 years.
The number of trials initiated in the UK has also declined. In 2021, there were 394 commercial trials initiated in the UK (interventional trials that have begun to recruit patients), compared to 471 in Spain, and all European countries were substantially behind China and the USA, with over 1,110 and nearly 2,000 initiated.
The O’Shaughnessy review was commissioned by the UK Government to put forward recommendations, having learnt from recent and historical successes, on how to improve the environment for running commercial clinical trials in the UK to reverse this decline.
Many proposals and a total of 27 recommendations are outlined in the O’Shaughnessy review and we discuss and highlight some of the most pertinent recommendations in this blog article. However, Lord O’Shaughnessy notes that “one thing more than any other needs to change: the attitude of everyone involved in health and care – public, patients, clinicians, NHS managers and politicians – towards the role of clinical trials in society. If the UK is truly going to be a science superpower, we have to use every asset at our disposal.”
Lord O’Shaughnessy writes “There is no reason why this cannot happen: we have the workforce, the scale, the data, the science base, the research charities and many other strengths, but arguably none is more significant than the NHS. A public commitment from leaders across the UK demonstrating that it is our ambition for the NHS to become the world’s leading platform for health and life sciences research, followed by a comprehensive plan of reform and a targeted set of key performance indicators (KPIs) against which progress can be transparently judged, would be a powerful signal of intent. And this signal must enable research to be prioritised within the context of the intense pressure that health and care services are under, and the demand for capacity, recognising the potential for research to transform care for the future.”
Some highlights from the 27 recommendations are listed below:
Compared to other countries, the UK has a slow and bureaucratic set-up and approval process for clinical trials to start. When measuring the time from application for regulatory approval to delivering the first dose to a participant for a selection of trials in 2020, the median time for the UK was 247 days. Whereas the USA, Spain and Australia all achieved median times of under 200 days.
Thereby, a rapid “task and finish” group should be set up to reduce the regulatory burden of approving trials and removing delays in set-up with the end goal of having a 60-day turnaround time for all approvals.
There is a lack of transparency about data and commercial clinical trial activity in the UK. Thereby, the UK government should set up a near real-time activity clinical trial directory - called ‘clinicaltrials.gov.uk’ - to create a single source of activity for patients, clinicians, researchers and potential trial sponsors.
There is a lack of accountability for the recent underperformance of clinical trials in the UK. Thereby, government departments (notably the Department of Health and Social Care & the Department for Science, Innovation and Technology) and the NHS should set annual targets for increasing commercial trials across the entirety of the UK. The recommendation from Lord O’Shaughnessy is that the central objective should be that recruitment to commercial clinical trials doubles within the next 2 years, with a further doubling by 2027.
Clinical trials and taking part in research has a low profile with the public in the UK, especially among disadvantaged or marginalised groups. Thereby, an ongoing public campaign should be conducted to promote research and to generate evidence on the most effective communication methods, in partnership with medical and research charities.
The final recommendation is that an action plan should be published and reported on publicly every year that provides objective accountability for the delivery of these recommendations, starting by autumn 2023.
Make 2nds Count welcomes these recommendations because without clinical trials, new medicines and treatments for secondary breast cancer will not be available for patients.
To support the secondary breast cancer clinical trial landscape and better enable patients to find trials, Make 2nds Count funds the Patient Trials Advocate (PTA) Service. The PTA is run by research nurses and provides an opportunity for patients to book an appointment to learn more about clinical trials in the UK and if they might be eligible to enrol into one. You can learn more about the PTA by clicking here and also see a registry of all actively recruiting clinical trials within the UK for secondary breast cancer by clicking here.
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