Publication details

Training and education on inclusivity in clinical trials-the SENSITISE project

Authors

SHIELY Frances RYCHLÍČKOVÁ Jitka KUBIAK Christine ČECHOVÁ Zora ESDAILE Martina TREWEEK Shaun

Year of publication 2024
Type Article in Periodical
Magazine / Source Trials
MU Faculty or unit

Faculty of Medicine

Citation
web https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08150-5
Doi http://dx.doi.org/10.1186/s13063-024-08150-5
Keywords clinical trials; training; education
Description There have been calls globally to improve participation in clinical trials of groups that traditionally have been under-represented. These under-served groups are populations under-represented or disengaged from medical research or services despite having a disproportionately high healthcare burden. INCLUDE, a 2017 initiative from the UK’s National Institute of Health Research (NIHR), has defined and identified under-served groups in clinical trials (elderly, ethnic minorities, the socioeconomically disadvantaged, pregnant and lactating women, the LGBTQ+ community, rural dwellers, those with comorbidities including disability, mental health conditions or cognitive impairment, amongst others) and barriers for recruitment. Trial conclusions cannot with certainty support treatment decisions (or mode of treatment delivery) for those not represented in the trial. This perpetuates inequality, is immoral and represents bad science. It can also lead to general distrust in research amongst under-served groups. Designing and conducting clinical trials is a complex task, and all involved agree that investigators need adequate training to perform their duties. Despite this, there is no formal training on inclusivity in clinical trials available globally.

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