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11th September 2023
Greater ethnic diversity in pioneering breast cancer clinical trials is the primary objective of a recent collaborative pilot project between Barts Health NHS Trust, The Christie NHS Foundation Trust, Roche Products Ltd and Macmillan Cancer Support.
The evidence derived from randomised controlled trials constitutes the most rigorous test of efficacy, effectiveness and safety for healthcare interventions. Nevertheless, if participants enrolled in these trials do not fully reflect the wider population for which the intervention is designed, the generalisability of the findings are limited.
What’s more, a 2016 study published in the British Journal of Cancer shows that young black women with breast cancer have more aggressive tumour profiles, present with later stages of disease, have higher mortality rates and experience poorer cancer care, yet they are often under-represented in clinical trials.
In an effort to redress this imbalance, this pilot project, which will run until August 2024, aims to increase the representation of black, Asian and ethnic minority women in breast cancer trials by improving access and identifying new and better ways to disseminate information.
This will include creating more targeted and meaningful communications for the communities the project is aiming to reach; increasing data, comparative baselines and patient retention records for research purposes; and providing enhanced support to ensure breast cancer patients understand the disease, what clinical research is and navigating patients to suitable clinical trials.
Findings and recommendations from the project will be used to create a case study and framework for future clinical trials and improve representation.
Dr Peter Hall, a medical oncology consultant at Barts Health NHS Trust who is involved in the project, said: ‘It’s well known that we need to do more to improve the diversity of participants taking part in the clinical trials we run at Barts Health and indeed, across the NHS. That’s why I’m so excited about this project.
‘By taking a targeted approach to driving diversity in clinical trials for a specific disease, we can not only improve representation for this condition, but learn how we can do this for trials into other conditions too. Ultimately, it will help us be more confident that the treatments we’re providing really do work for everyone. It’s also great to see this project being run as a collaboration between the NHS, charity and the commercial sector.‘
Understanding why clinical trials have historically under-represented people of different ethnicities remains unclear. Some reasons include the need for a narrowly defined, homogenous population to reduce variance and hence sample size, together with the imposition of stringent inclusion and exclusion criteria.
A further possible reason is the lack of engagement with ethnic communities. According to Charles Kwaku-Odoi, chief executive of the Caribbean African Health Network, ‘across the black community there is an undoubted legacy of disengagement in research and most certainly clinical trials that stems back decades as a result of mistrust. This has not served us well because it leads to a lack of appropriate interventions that perpetuate the grave health inequalities in breast cancer care‘.
He added: ‘This partnership approach to build solutions to improve engagement in clinical trials in breast cancer treatment and care is very much welcomed. We are looking forward to working in a collaborative way to build trust, improve awareness and ensure that barriers surrounding access to clinical trials are addressed.‘
In 2020, the INCLUDE group set out a multicomponent work stream project to improve representation of under-served groups in clinical trials. Under-representation of patients from different ethnicities is a recognised problem. For instance, research has revealed a lack of ethnic diversity within lipid lowering drug trials.
26th May 2023
The UK Government has announced five funding commitments totalling £121m to accelerate commercial clinical trials, making it easier for revolutionary healthcare treatments to reach patients and helping to cut NHS waiting times.
The commitments include measures to make the approvals and set up of trials quicker, with the aim of approving all trials within 60 days, and improving trial recruitment through increased transparency and accessibility of clinical trial data. This will make it easier for people to find trials via real-time information and for NHS organisations to contact patients who could benefit from ground-breaking treatments.
A joined-up approach to clinical trials across the country will also be established through the creation of Clinical Trial Acceleration Networks. These will focus on accelerating priority areas of research, creating exemplars for delivering trials in key areas, such as cancer and infectious disease, to improve delivery of all trials based on best practice.
The Government acknowledged clinical research as the single most important way to improve healthcare – by identifying the best way to prevent, diagnose and treat conditions – and identified clinical trials as part of the solution for reducing strain on the NHS.
The announcement comes in response to the publication of the Lord O’Shaughnessy Review into commercial clinical trials in the UK.
This much-anticipated independent review, commissioned by the Government in February 2023, offers 27 recommendations, addressing eight problem statements, on how the Government should work to resolve key challenges in conducting commercial clinical trials in the short and longer term.
This includes the need for clinical research to be be systemically prioritised by or within the NHS, and for incentives to offered to doctors, nurses and NHS organisations to take part in clinical research, especially when it is commercially funded.
Indeed, evidence shows hospitals which undertake research have better patient care outcomes, improved staff retention and it benefits the whole health and care system.
The Government has welcomed all recommendations from the Review, with health and social care secretary Steve Barclay saying: ‘This investment is another significant step in harnessing UK innovation to help cut waiting lists – one of the Government’s five priorities – and build a stronger NHS.
“We will take forward Lord O’Shaughnessy’s recommendations to speed up the delivery of clinical trials and boost patient involvement in research, so people getting NHS care can benefit from cutting-edge treatments faster, supported by £121m in government funding.’
The Review also highlights the potential for commercial clinical trials to take place in primary care and at-home settings and the need for regulators to produce guidance to support these decentralised trials.
A report into the progress of the Government’s commitments to Lord O’Shaughnessy’s recommendations, as well as responses to those recommendations requiring further research, will be published in autumn 2023.
Richard Torbett, chief executive, Association of the British Pharmaceutical Industry, said: ‘Lord O’Shaughnessy is right that making the UK an attractive destination for industry clinical trials requires regulatory reform, speedier study set-up and approvals, and improved access to data. Implementing his proposals, alongside these other announcements, can be a springboard to delivering on the UK’s ambition to be a science superpower, and we now must press forward with delivery at pace.’
Executive director of policy, information and communications at Cancer Research UK, Dr Ian Walker, said: ‘The O’Shaughnessy Review has rightly recognised that the UK’s clinical trials system needs to change. The system has been under pressure for many years, but has been pushed close to breaking point by the pandemic and related pressures on the NHS.
‘Many of the review’s recommendations recognise the value that medical charities like Cancer Research UK bring to clinical trials, offering patients early access to innovative new treatments. Taking trials to sites outside of hospitals and cutting red tape will help get more trials up and running, get more patients joining trials and make faster progress towards new treatments.
‘But fundamentally we must urgently address the lack of time and capacity available for research within the NHS. Right now, staff within cancer services are overstretched, struggling to set aside time to deliver promising clinical trials which could ultimately make smarter use of the NHS.’
Dr Samantha Walker, Director of Research and Innovation at Asthma + Lung UK, said: ‘I’m pleased Lord O’Shaughnessy’s review highlights the areas where clinical trials aren’t currently working in the UK and that the Government proposes to accept his recommendations. Clinical trials are an essential part of developing new and better treatments for people. However, without a consistent way to connect people in need of treatment with the appropriate trial, the system supporting clinical research in the UK breaks down and faces collapse.’
Mr Hunt’s ‘Life Sci for Growth’ package, announced on 25 May 2023, brings together 10 policies to ‘fire up the UK’s life sciences sector’, backed by cross-government package of £643m.
As well as focusing on clinical trial improvements, other health-related policies include up to £48m of new money for scientific innovation to prepare for any future health emergencies, and £154m to increase capacity of the UK’s biological data bank.
Plans were also unveiled to plans to relaunch the Academic Health Science Network as ‘Health Innovation Networks’ to boost innovation by bringing together the NHS, local communities, charities, academia and industry to share best practice.
Mental health was another priority, with £42.7m of investment for the ‘Mental Health Mission’, which will go towards the research and delivery of novel treatments for early intervention in psychosis, depression and mental health in children.
Mr Barclay added: ‘We’re also accelerating research into mental health, backed by over £42 million of investment in clinical research centres across the UK – including in Birmingham and Liverpool – to improve the speed and accuracy of diagnosis and increase the use of technology for treatment.’