Equality, diversity and inclusion research

The DISTINCT project is looking for the best way to collect information about personal characteristics from study participants. This will help us see who is taking part in our trials and make changes to ensure wider access to research. DISTINCT is a joint project between the Clinical Trial and Statistics Unit at the Institute of Cancer Research (ICR-CTSU) and the Cancer Prevention Trials Unit (CPTU) at Queen Mary University of London (QMUL).

Our SPRUCE study is investigating collection methods for questionnaires completed by our trial participants. We are looking into whether online completion of questionnaires is as good as our current approach using paper questionnaires. We are continuing to offer participants the choice of paper questionnaires, rather than switching to electronic questionnaires for everyone. We will use the results of the SPRUCE study to confirm the best way to offer questionnaires to our trial participants in future. We will also investigate whether there are some groups of people who prefer to complete questionnaires on paper rather than electronically, so that we can make sure that this option is always 

Cancer research studies check whether new treatments are safe and work as intended. People who take part in these studies should be similar to those affected by the cancer, from different ethnicities and backgrounds. This helps to make sure no-one is excluded and that the results of the research apply to all cancer patients.

INTERACT aims to find out:

Whether in the past there were any differences between people who took part in research into cancer treatments in the UK and those who didn’t?

Who is less likely to take part in cancer research in hospitals today? And is this because they don’t know about the research or because they choose not to take part?

Can we build strong relationships with people from different backgrounds to understand how to support wider participation in research?

We conducted an audit of trials led by ICR-CTSU which started between 2011 and 2021. The aim of the review was to see if we had any obvious issues in our trial protocols or supporting paperwork which would cause routine exclusion of any groups of people. We also reviewed whether we collected enough information about our trial participants to identify whether any particular groups were being excluded. We based our audit on the NIHR’s INCLUDE definition of under-served groups and reviewed protocols, patient information sheets, questionnaires and data collection forms.Results were published in BMC Medical Ethics in November 2023. We reviewed 30 clinical trials. There were no systematic issues with our protocols’ inclusion criteria. Our patient information sheets had a reading age of 15-16 years and frequently used gendered terms. Although we routinely collected age, sex and ethnic group, we did not collect enough data to assess whether people may be in under-served groups identified by the INCLUDE project.

We have since updated our processes to try and improve readability of patient information and reduce use of gendered terms. We have a number of ongoing projects investigating other potential improvements, including working with patient advisors to expand our collection of demographic data.

We contributed to a study led by The University of Sheffield exploring the importance of equality, diversity and inclusion in early phase trials. Results were published in BMJ Open in 2024, recommending that inclusivity should be considered in all early-phase trials.

We contributed to The Lancet Breast Cancer Commission working with Professor Charlotte Coles, Dr Indrani Bhattacharya and patient and public representatives on the CASCARA project. We surveyed people with experience of breast cancer diagnosis and treatment in the UK to explore the hidden costs and supportive care needs associated with breast cancer. Initial results were published in The Lancet in 2024. Six-hundred and six people responded to the patient survey. 20% of participants with early breast cancer and 25% of those with metastatic breast cancer reported difficulty in covering costs of travel for treatment.

Our PhD candidate, Georgiana Synesi, worked on this project from 2022-2025. She first identified underrepresented groups amongst ICR-CTSU trial participants compared to the wider population. She conducted a scoping review of UK-wide trial eligibility criteria to investigate whether any under-served groups were systematically excluded. She then led a mixed-methods recruitment study (REPRESENT) exploring who is invited to join trials, who accepts, and the reasons why. The study investigated routinely collected demographic data, and patterns in trial invitations and acceptance with patients and staff involved in recruitment. The results from these projects were used to co-develop a set of recommendations around how trials are designed (for researchers) and how they are carried out (for staff involved in recruitment).

This was a MRC-NIHR Trials Methodology Research Partnership (TMRP) & Doctoral Training Partnership.