Abstract
Research shows that participants in clinical trials rarely reflect the populations that could benefit from the treatments being tested, for example, COVID-19 disproportionately affected older people and those from ethnic minority backgrounds but these groups were underrepresented in the research. The INCLUDE project, commissioned by the NIHR, identified a range of “underserved” groups, which can vary across the types of studies, disease or condition being studied, but there are some common barriers to trial participation across groups, such as the research burden, language and communication differences and a lack of trust and engagement in healthcare and research.
A focus on inclusivity by funders has encouraged researchers to think about how to design and conduct research that accessible to the population that needs the research, but researchers are not sure where to start!
This mini-masterclass will present the key messages from the Socioeconomic Framework, which guides researchers with questions to consider when designing research. The session will also discuss the findings from a trial methodology project (funded by NIHR CTU Support Funding scheme) that identified design features to make research more inclusive. I will present evidence from the literature in the UK and Ireland, findings from roundtable discussions with trial methodologists, research staff, clinicians and patients and combine this with the key questions in the Socioeconomic Framework to help researchers make their research more inclusive.
Bio
Katie Biggs is an Assistant Director of Sheffield Clinical Trials Research Unit (CTRU) and an NIHR pre-doctoral fellow at the University of Sheffield. Katie started work in CTRU as a trial manager, managing multicentre RCTs in the NHS and became interested in trial methodology to promote efficient and scientific methods for conducting RCTs. Katie now designs trials and oversees the conduct of trials in the CTRU and her pre-doctoral fellowship is a training and development fellowship that is focussed inclusivity of complex intervention research and evaluation.
https://www.sheffield.ac.uk/scharr/people/staff/katie-biggs