SENSITISE (Inclusive clinical trials education)
@sensitise-eu.bsky.social
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ERASMUS+ Cooperation Partnerships funded grant to develop free training and education materials for trialists
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sensitise-eu.bsky.social
Oct #MethodologyMonday focuses on a recent editorial: the usefulness of trial data depends crucially on transparent, consistent reporting of who was actually enrolled, not could have been. Trials will introduce a requirement to address this (01/2026).
trialsjournal.biomedcentral.com/articles/10....
Who is in your trial? Improving the reporting of participant characteristics in trial protocols and results - Trials
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trialsjournal.biomedcentral.com
sensitise-eu.bsky.social
The last September #MethodologyMonday includes input from the consortium on improving the inclusion of those with impaired capacity with the dedicated INCLUDE framework. This article outlines the development of this dedicated framework.

trialsjournal.biomedcentral.com/articles/10....
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In the mixed-methods systematic review carried out by Stokes et al, not only were barriers identified, but also facilitators for the implementation of capacity legislation in care homes.

#MethodologyMonday
pubmed.ncbi.nlm.nih.gov/40370080/
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Gréaux et al identified barriers across the health system (cost, training, coordinated service) and wider contributing factors (social stigma or health literacy). Moreover, the solutions proposed dont necessarily address these needs
#MethodologyMonday
equityhealthj.biomedcentral.com/articles/10....
sensitise-eu.bsky.social
September #MethodologyMonday will focus on the inclusion of persons with disabilities. First, a call to action from Anderson and colleagues for disability inclusion in health research.

(not open access)
www.nature.com/articles/s41...
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The Digital Cancer Research and Vocal co-developed this week’s #MethodologyMonday guidance with patients. They came up with 5 principles for the development of technology clinical trials and an accompanying checklist.

christie.openrepository.com/bitstream/ha...
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Reposted by SENSITISE (Inclusive clinical trials education)
sensitise-eu.bsky.social
Direct from our consortium, an article on the development of the STEP UP guidance to help researchers design inclusive clinical trials. Learn more about the Strategies for Trialists to promote Equal Participation in clinical trials for Under-served Populations.

link.springer.com/article/10.1...
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In this hashtag#MethodologyMonday, Chokkara et al. look at the recruitment of underrepresented populations in COVID-19 studies conducted in the US and found: they exclude people with high-risk chronic conditions & trials excluded children, pregnant & lactating women
link.springer.com/article/10.1...
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#MethodologyMonday: a call to action from Reza and colleagues for the inclusion of all populations impacted by heart failure with reduced ejection fraction in clinical trials. They also catalogue barriers & propose strategies to ⬆️ inclusivity in future trials.

academic.oup.com/eurheartjsup...
Representation matters: a call for inclusivity and equity in heart failure clinical trials
Abstract. The burden of heart failure remains substantial worldwide, and heart failure with reduced ejection fraction (HFrEF) affects approximately half of
academic.oup.com
sensitise-eu.bsky.social
For #MethodologyMonday, we revisit the impact of exclusion criteria on sex and race. Stanton et al investigated the potential impact that common exclusion criteria by race and sex have on trial eligibility of patients with ischemic stroke.

www.ahajournals.org/doi/full/10....
Clinical Trial Exclusion Criteria Affect Trial Inclusivity by Race and Sex | Journal of the American Heart Association
www.ahajournals.org
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How is diversity integrated into decentralised clinical trials? The authors list 2 key areas linked to participant selection that should be prioritised for #MethodologyMonday.

Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups. doi.org/10.1186/s129...
Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups - BMC Medical Ethics
Background The importance of more diversity of study populations in clinical trials is currently widely acknowledged. Decentralized clinical trial (DCT) approaches are presented as a potential means to broaden diversity by eliminating several barriers to participation. However, the precise meaning of, and objectives related to diversity in DCTs remain unclear. Diversity runs the risk of becoming a ‘buzzword’: widely acknowledged to be important, yet prone to multiple interpretations and challenging to implement in practice. We argue that the aim of increasing diversity in clinical trials requires clear and well-substantiated specifications. Methods We analyze the concept of diversity and the ethical requirements surrounding fair participant selection within the context of clinical research, in order to further specify and operationalize the aim of increasing diversity in the context of DCTs. Results Through analyzing the concept of diversity and ethical requirements for fair participant selection, we propose that diversity should be specified in a way that improves the position of the groups that are currently most underrepresented in the research context. In practice, this entails that, in order to contribute to diversity, the selection of participants should prioritize (i) gaining scientific knowledge on groups for which this is lacking, and (ii) inclusion of underrepresented groups in research when appropriate considering a study’s objectives, and risks and benefits. Conclusions Our analysis facilitates translating the aim of increasing diversity with DCTs to more specific and actionable objectives for recruitment and inclusion. Moreover, it contributes to a further specification of the concept of diversity and fair participant selection in research contexts.
doi.org
sensitise-eu.bsky.social
For #MethodologyMonday we focus on this rapid communication on the impact linked to common exclusion criteria by race and sex on trial eligibility of patients with ischemic stroke in the USA.
Stanton et al. (2024) doi.org/10.1161/JAHA...
Clinical Trial Exclusion Criteria Affect Trial Inclusivity by Race and Sex | Journal of the American Heart Association
doi.org
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To kick off #MethodologyMonday in May, we bring you a poignant article by the Editors in Chief of the Journal of Clinical Epidemiology. They address the “elephant in the room”, the upheaval of the global evidence research eco-systems pursued by the US administration.
www.jclinepi.com/article/S089...
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This literature review identified strategies to enhance the racial & ethnic diversity of breast cancer trial populations. It resulted in 8 key strategic themes, which were used to create a new Racial and Minority Growth model.
#MethodologyMonday
Scott & Westwell
orca.cardiff.ac.uk/id/eprint/17...
orca.cardiff.ac.uk