A capability framework to inform the fundamental requirements for clinical trial unit development, growth and long term success in outer metropolitan and rural areas.
Delivery of health care
Humans
Randomized controlled trials as topic/methods
Regional
Rural population
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
16
08
2022
revised:
20
12
2022
accepted:
14
01
2023
entrez:
30
1
2023
pubmed:
31
1
2023
medline:
31
1
2023
Statut:
epublish
Résumé
Participation in clinical trials is linked to improved patient outcomes. Despite this, most trial participants either reside in, or are treated in metropolitan areas. TrialHub developed hub-and-spoke models to support and grow clinical trial units in outer metropolitan and regional/rural centres in order to boost clinical trial engagement and reduce demands of trial participation on patients from outer metropolitan and regional/rural areas. The aim of this project was to establish a capability framework for clinical trial unit growth and development. An integrative methods study design was used to inform the co-design and development of the capability framework based on data collected in Victoria during 2020-21. This included reviews of the literature and of existing local resources, infrastructure, and staffing; as well as education, mentoring and support, and a needs assessment through multidisciplinary working groups. We developed a capability framework based on the level of support required for outer metropolitan and regional/rural centres with diverse existing capabilities across Victoria. The framework applies a maturity model to assess resources, processes and practices which impact the capacity and capability of centres to conduct trials safely and sustainably. Each level of the model uses a consistent set of factors to describe the core elements required for safe clinical trial delivery. This benchmarking allows targeted investment to ensure safe and high-quality delivery of trials at newly establishing trial units. The capability framework developed by TrialHub provides a basis for staged, planned and successful trial unit development and trial implementation. Further validation of the framework is required.
Sections du résumé
Background
UNASSIGNED
Participation in clinical trials is linked to improved patient outcomes. Despite this, most trial participants either reside in, or are treated in metropolitan areas. TrialHub developed hub-and-spoke models to support and grow clinical trial units in outer metropolitan and regional/rural centres in order to boost clinical trial engagement and reduce demands of trial participation on patients from outer metropolitan and regional/rural areas. The aim of this project was to establish a capability framework for clinical trial unit growth and development.
Methods
UNASSIGNED
An integrative methods study design was used to inform the co-design and development of the capability framework based on data collected in Victoria during 2020-21. This included reviews of the literature and of existing local resources, infrastructure, and staffing; as well as education, mentoring and support, and a needs assessment through multidisciplinary working groups.
Results
UNASSIGNED
We developed a capability framework based on the level of support required for outer metropolitan and regional/rural centres with diverse existing capabilities across Victoria. The framework applies a maturity model to assess resources, processes and practices which impact the capacity and capability of centres to conduct trials safely and sustainably. Each level of the model uses a consistent set of factors to describe the core elements required for safe clinical trial delivery. This benchmarking allows targeted investment to ensure safe and high-quality delivery of trials at newly establishing trial units.
Conclusion
UNASSIGNED
The capability framework developed by TrialHub provides a basis for staged, planned and successful trial unit development and trial implementation. Further validation of the framework is required.
Identifiants
pubmed: 36712185
doi: 10.1016/j.conctc.2023.101072
pii: S2451-8654(23)00018-2
pmc: PMC9876817
doi:
Types de publication
Journal Article
Langues
eng
Pagination
101072Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Références
JCO Oncol Pract. 2020 Sep;16(9):e849-e858
pubmed: 32240068
J Community Health. 2013 Aug;38(4):642-51
pubmed: 23468319
Am J Health Promot. 2015 May-Jun;29(5):332-8
pubmed: 24670073
Asian Pac J Cancer Prev. 2011;12(11):3153-6
pubmed: 22394007
BMC Med Educ. 2016 Jan 14;16:13
pubmed: 26768258
Biol Blood Marrow Transplant. 2013 Jun;19(6):858-9
pubmed: 23545332
J Community Health. 2014 Jun;39(3):562-71
pubmed: 24310703
Patient Educ Couns. 2011 Nov;85(2):e69-74
pubmed: 21458194
Cancer. 2008 Jan 15;112(2):228-42
pubmed: 18008363
Patient Educ Couns. 2020 Oct;103(10):2142-2154
pubmed: 32601042
Pediatrics. 2020 Oct;146(4):
pubmed: 32943534
JCO Oncol Pract. 2020 Jul;16(7):422-430
pubmed: 32574128
J Clin Transl Sci. 2021 Apr 08;5(1):e136
pubmed: 34367680
Am Soc Clin Oncol Educ Book. 2016;35:185-98
pubmed: 27249699
Curr Oncol. 2021 Sep 30;28(5):3857-3865
pubmed: 34677247
Trials. 2017 Aug 1;18(1):360
pubmed: 28764809
Health Policy. 2014 Feb;114(2-3):183-91
pubmed: 23764153
Curr Opin Pediatr. 2018 Apr;30(2):297-302
pubmed: 29517535
BMJ Open. 2015 Dec 09;5(12):e009415
pubmed: 26656023