Informace o publikaci

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

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

Rok publikování 2024
Druh Článek v odborném periodiku
Časopis / Zdroj Trials
Fakulta / Pracoviště MU

Lékařská fakulta

Citace
www https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08150-5
Doi http://dx.doi.org/10.1186/s13063-024-08150-5
Klíčová slova clinical trials; training; education
Popis 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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