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

SHIELY, Frances, Jitka RYCHLÍČKOVÁ, Christine KUBIAK, Zora ČECHOVÁ, Martina ESDAILE and Shaun TREWEEK. Training and education on inclusivity in clinical trials-the SENSITISE project. Trials. LONDON: Elsevier, 2024, vol. 25, No 1, p. 1-2. ISSN 1745-6215. Available from: https://dx.doi.org/10.1186/s13063-024-08150-5.

Basic information

• Original name: Training and education on inclusivity in clinical trials-the SENSITISE project
• Authors: SHIELY, Frances, Jitka RYCHLÍČKOVÁ (203 Czech Republic, belonging to the institution), Christine KUBIAK, Zora ČECHOVÁ (203 Czech Republic, belonging to the institution), Martina ESDAILE and Shaun TREWEEK.
• Edition: Trials, LONDON, Elsevier, 2024, 1745-6215.

Other information

• Original language: English
• Type of outcome: Article in a journal
• Field of Study: 30230 Other clinical medicine subjects
• Country of publisher: United Kingdom of Great Britain and Northern Ireland
• Confidentiality degree: is not subject to a state or trade secret
• WWW: URL
• Impact factor: Impact factor: 2.500 in 2022
• Organization unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.1186/s13063-024-08150-5
• UT WoS: 001222713100001
• Keywords in English: clinical trials; training; education
• Tags: 14110516, rivok
• Tags: International impact, Reviewed

Abstract

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.