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Methodology Monday November Roundup

30 Nov 2025

To begin November's #MethodologyMonday roundup, Booth et al presents case studies from three NIHR-funded trials demonstrating how publicly available UK population datasets can be used to identify under-served communities and improve inclusivity in clinical research. They reflect on the challenges and future developments of their approach.

Ref. Booth A, McDaid C, Scrimshire A, Singh HP, Scantlebury A, Hewitt C. Using publicly available UK datasets to identify recruitment sites to maximise inclusion of under-served groups: three case studies. NIHR Open Res. 2024

Next, we focus on this 2022 review by Mohan and Freedman on the persistent under-representation of racial and ethnic minorities in clinical trials, which highlights how this limits the generalisability of safety and efficacy data. They survey key structural and regulatory barriers to participation - such as restrictive eligibility criteria, mistrust, and logistical constraints — and describe recent initiatives and trial designs that have successfully increased diversity. Finally, they argue that pursuing representative enrollment throughout clinical development is not only a matter of equity but also of scientific rigour, as it improves our ability to assess benefit–risk profiles across all populations.

Ref. Mohan, S.V. & Freedman J. (2022). A review of the evolving landscape of Inclusive Research Improved Clinical Trial Access. Clinical Pharmacology & Therapeutics, 113.

SENSITISE - Inclusive Clinical Trials: Training and Education

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