Equality, Diversity and Inclusion (EDI) in early phase trials

Representation (also known as EDI or equality, diversity and inclusion) is important in clinical trials as trial results should be relevant to all populations that might benefit from the treatment being studied, and all individuals should have equal access to potentially beneficial trial treatments.



Early phase trials are small studies undertaken in humans to understand aspects of a new drug (their safety, how much is safe to give and how the body deals with the treatment) before testing the drug further.

The importance of EDI in early phase trials is not understood. This is partly because these early phase trials are usually quite small (often less than 20 participants); making it challenging to include multiple patient groups (eg ethnicities) in a given study. There may also be barriers faced by patients in being aware of, or participating in, early phase trials, which may be made worse by the high-risk nature of these trials. 

Our research plan

In this study, we will interview around 10 individuals that are involved in early phase trials, including clinicians and researchers. The interviews will explore their views on the value and relevance of EDI in early phase trials, if (and how) they have incorporated EDI into early phase trials, and any challenges of doing so.

We will also interview patients and research participants to explore their views on the value of and the challenges of taking part in early phase trials. The interviews will be analysed and themes identified.

The findings from this study will help those undertaking early phase trials to decide if, when, and how, to include EDI in their research.

If you are interested in participating in this study please contact Robin Chatters (r.chatters@sheffield.ac.uk)

Research team

Robin Chatters: Research Fellow, Sheffield Clinical Trials Research Unit, The University of Sheffield

Professor Cindy Cooper: Professor of Health Services Research and Clinical Trials, Sheffield Clinical Trials Research Unit, The University of Sheffield

Dr Munya Dimairo: Senior Research Fellow/Medical Statistician, Sheffield Clinical Trials Research Unit, The University of Sheffield

Tim Sprosen: Director, Early Phase Clinical Trials, Faculty of Health, The University of Sheffield

Katie Biggs: Assistant Director/NIHR Pre-doctoral Research Fellow, Sheffield Clinical Trials Research Unit, The University of Sheffield

Dr Alex Rothman: Wellcome Trust Clinical Research Career Development Fellow, School of Medicine and Population Health, The University of Sheffield 

Professor Fiona Thistlethwaite: Medical Oncology Consultant, The University of Manchester and The Christie NHS Foundation Trust

Professor Christina Yap: Professor of Clinical Trials Biostatistics, The Institute of Cancer Research (London) 

Della Ogunleye: Patient representative


Participant information sheet – Public and research participants (PDF, 145KB)

Participant information sheet – Professionals (PDF, 141KB)

Consent form (PDF, 125KB)

Study protocol (PDF, 150KB)

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