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Methodology Monday October Roundup
To kick of #MethodologyMonday in October we will focus on a recent editorial which highlights the usefulness of trial data depends crucially on transparent, consistent reporting of who was actually enrolled - not just who could have been.
To address this, the journal Trials is introducing a new requirement (from January 2026) that submitted trial protocols must include a dedicated “participant characteristics table,” covering six core demographic domains (from the PRO-EDI initiative): age; sex; gender; race/ethnicity/ancestry; socioeconomic status; and geographic location. The same table must then be updated in the final trial report with observed values and, ideally, outcome data disaggregated by those characteristics. While the completeness of this data may not always be possible transparency about missingness or limitations is preferable to silence.
Ref. Treweek, S., Dawson, S., Khunti, K. et al. Who is in your trial? Improving the reporting of participant characteristics in trial protocols and results. Trials 26, 338 (2025). doi.org/10.1186/s13063-025-08938-z
An audit at a UK primary care clinical trials unit assessed the inclusion of under-served groups in trials in this #MethodologyMonday. It reviewed trial protocols, patient information sheets, and data collection tools to identify explicit exclusion criteria and assess whether protected characteristics or under served group status were captured for 19 trials identified between 2017-2023.
It found that common exclusions were concerned age limits, language fluency, capacity to consent, pregnancy, and disease severity, among others while data collection was inconsistent in capturing key under served group variables like ethnicity, education, and mental health. The authors conclude that many explicit exclusions may not be strictly necessary, limiting trial generalisability, and call for more inclusive eligibility criteria and standardised data collection to better assess representation in clinical trials.
Ref. Burrow, R., Carr, M., Goddard, L. et al. Inclusion of under-served groups in trials: an audit at a UK primary care clinical trials unit. Trials 26, 219 (2025). doi.org/10.1186/s13063-025-08893-9
A new #MethodologyMonday from Raven-Gregg & Shepherd focuses on ethnic minority populations’ views on deferred consent. Deferred consent (i.e. enrolling first and obtaining consent later) is used in emergency research when prior consent is not possible, and may help include participants who otherwise would be excluded. However, methodology studies on attitudes to deferred consent often poorly represent ethnic minority groups: many don’t report participants’ ethnicity or lump diverse groups together. Among the studies that report by ethnicity, people from minority backgrounds often express greater reluctance toward deferred consent, influenced by prior experience and mistrust of research systems. The authors argue that to make clinical trials and consent methodology research more equitable, we need better reporting in methodological research, and greater diversity in research teams and ethics committees.
Ref. Raven-Gregg, T., Shepherd, V. Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent. Trials 22, 589 (2021). doi.org/10.1186/s13063-021-05568-z
Gillibrand et al applied a qualitative approach (interviews and focus groups) to understand barriers to cervical screening and reactions to self sampling methods where under screened/ under-served populations were concerned. Both positive and negative experiences focused on the healthcare provider. Self sampling via vaginal swab or urine was generally seen positively: it offered greater choice, autonomy, removal of the invasive speculum, and convenience (e.g. do at home) — though concerns remained. The authors argue that self sampling could help reduce screening disparities if implemented with careful user information, communication, and sensitivity to diverse needs; without these safeguards, benefits may not be realised.
Ref. Gillibrand, S., Gibson, H., Howells, K. et al. Exploring the barriers to cervical screening and perspectives on new self-sampling methods amongst under-served groups. BMC Health Serv Res 25, 79 (2025). doi.org/10.1186/s12913-024-12098-2
