Let's talk about...
Addressing Inclusion in Clinical Research
Addressing Inclusion in Clinical Research
December 2023 saw the return of the ‘Let’s talk about…’ EDI seminar series for its ninth edition, in partnership with CRUK City of London and Cambridge Centres. Our researchers from Manchester and Cambridge covered ‘Addressing Inclusion in Clinical Research’.
Delivering the keynote was Dr Donna Graham, a Medical Oncology consultant within the Experimental Cancer Medicine Team at The Christie Hospital in Manchester. On the panel was Alice Groves, Principal Research Nurse and Co-ordinator in the ACED Clinic Cambridge team.
Dr Donna Graham, Medical Oncology Consultant within the ECMC
Donna covered various aspects of early phase clinical trial design and a range of issues which contribute to health inequalities in clinical trials, including:
- Data relating to protected characteristics is often missing or incomplete, reducing the understanding of clinical trial composition
Donna also discussed clinical trials in The Christie Hospital, Manchester, supplemented by Alice’s experiences working in Cambridge:
- 730k people took part in NIHR supported trials in England in 2019-20, rising to 1.4M people in 2020-21
- Between Dec 2019 – May 2020 – 1,518 COVID-19 studies were registered on ClinicalTrials.gov, but only 6 collected data on ethnicity despite it being widely known that minority ethnic groups are more likely to suffer severe illness or death from the virus (Pan et al., 2020)
Alice Groves, Principal Research Nurse and Co-ordinator in the ACED Clinic Cambridge team
Alice discussed her role as a Principal Research Nurse and trial coordinator, offering her insights into how health inequalities present and become more evident as the trial is carried out, including:
- The need for outreach to community leaders and established advocacy groups to understand the needs of local people
- Gearing studies towards recognising diversity such as skin tone with Cambridge’s photo-acoustic imaging pilot study
Conclusions and implications
- Developing pathways to improve inclusion at each part of the research pathway
- Challenging design exclusions and trial design such as for HIV+ patients who may be excluded reasons unrelated to the trial itself
- Working with funders to advocate for stricter accountability in funding decisions and reporting or governance structures.
Speaker profiles
Dr Donna Graham
Donna is a Medical Oncology Consultant within the Experimental Cancer Medicine Team. She serves as clinical lead on the Technology Clinical Trials team in digital ECMT and Research Digital Programme Board at The Christie Hospital. She has a decade of experience in cancer clinical trials with a focus on early phase research and, more recently, use of technology for patient benefit.
She is an Honorary Lecturer at The University of Manchester, Manchester Lead on the Experimental Cancer Medicine Centres (ECMC) North Digital Committee in the UK and a work package lead in the international UpSMART Consortium, investigating and promoting use of technology in Early Phase Oncology Trials. She is driven to improve patient outcomes and experience through adoption of technology supported by evidence through the technology clinical trial.
Alice Groves
Alice Groves is Principal Research Nurse and Co-ordinator in the ACED Clinic Cambridge team. The ACED Clinic Cambridge’s goal is to facilitate early-stage trials of novel diagnostic and predictive technologies for the Early detection of cancer from Research from across the ACED Alliance. Currently they are facilitating multiple studies including:
- Recruiting and working on the ACED Cohort study which aims to recruit 1000 volunteers aged 40-80 returning annually for up to ten years
- Gathering information on demographic, physiological, epidemiological, and cognitive data through questionnaires and interactive tasks, as well as collecting biological samples
- Working on a photo-acoustic imaging pilot study designed to explore whether skin pigmentation or skin tone influences photoacoustic imaging.
She has a specific interest in increasing diversity of participants taking part in the early cancer detection studies the ACED Clinic Cambridge support.
