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.‘
A lack of ethnic diversity in clinical trials
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.