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Methodology Monday July Roundup

31 Jul 2025

The COVID-19 pandemic has increased awareness of the need to include patients traditionally underrepresented in research. In this #MethodologyMonday, we zoom in on Chokkara et al. who looked at the recruitment of underrepresented populations in COVID-19 studies conducted in the US and found they excluded people with high-risk chronic conditions, and most trials excluded children, pregnant women, and lactating women.

Ref. Chokkara S, Volerman A, Ramesh S, Laiteerapong N. Examining the inclusivity of US trials of COVID-19 treatment. Journal of General Internal Medicine. 2021 May;36:1443-5.

We’ve already shared this article but not as part of our #MethodologyMonday series. Direct from our consortium, Frances Shiely & Shaun Treweek contributed to the development of the STEP UP guidance to help researchers design inclusive clinical trials. This guidance includes input from the ACCESS team as well as the public contributors. The article in question outlines how they were developed. The resulting Strategies for Trialists to promote Equal Participation in clinical trials for Under-served Populations

Ref. Biggs K, Hullock K, Dix C, Lane JA, Green H, Treweek S, Shiely F, Shepherd V, Willis A, Isaacs T, Cooper C. Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials. BMC Medical Research Methodology. 2024 Oct 2;24(1):227.

The Digital Cancer Research and Vocal co-developed this week’s #MethodologyMonday guidance with patients. They held online workshops to review how inclusivity can be supported from the research question development to the trial management. Through the course of these efforts, they came up with 5 principles for the development of technology clinical trials. To support the work, they developed an interactive checklist intended for use by the research team throughout the trial development process. 

Ref. Digital Cancer Research and Vocal (2024). Encouraging Inclusivity in Technology Clinical Trials: Guidance co-developed by patients, members of the public, clinical staff and researchers. The University of Manchester, UK

This #MethodologyMonday is in line with the SENSITISE outcomes. Passmore and colleagues used a survey to understand the difference between knowledge and implementation of inclusivity in research. Their results showed that federal funding, years of experience, recruitment of healthy participants and dedicated training on recruitment impact individuals knowledge base and experience. 

Ref. Passmore SR, Edwards DF, Sorkness CA, Esmond S, Brasier AR. Training needs of investigators and research team members to improve inclusivity in clinical and translational research participation. Journal of Clinical and Translational Science. 2021 Jan;5(1):e57.

SENSITISE - Inclusive Clinical Trials: Training and Education

Co-funded by the European Union through the EU ERASMUS + programme (2023-1-IE02-KA220-HED-000159532),

The work by SENSITISE project consortium is licensed under CC BY 4.0

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