J 2024

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

SHIELY, Frances, Jitka RYCHLÍČKOVÁ, Christine KUBIAK, Zora ČECHOVÁ, Martina ESDAILE et. al.

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

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 2.500 in 2022

Organization unit

Faculty of Medicine

UT WoS

001222713100001

Keywords in English

clinical trials; training; education

Tags

Tags

International impact, Reviewed
Změněno: 11/7/2024 13:40, Mgr. Tereza Miškechová

Abstract

V originále

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.