Evidence map›Paper›PMID 36712185›Full record

ArticleContemporary clinical trials communications2023

A capability framework to inform the fundamental requirements for clinical trial unit development, growth and long term success in outer metropolitan and rural areas.

Anne Woollett, Jhodie Duncan, Mark Voskoboynik, Mark Shackleton, Michael Dooley, Robert Blum, Narelle McPhee, Tricia Wright, Zee Wan Wong, Jacqueline Dixon and 1 more

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.0field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Anne WoollettTrialHub, Alfred Health, Melbourne, Victoria, Australia.
Jhodie DuncanLatrobe Regional Hospital, Traralgon, Vic, Australia.
Mark VoskoboynikTrialHub, Alfred Health, Melbourne, Victoria, Australia.
Mark ShackletonTrialHub, Alfred Health, Melbourne, Victoria, Australia.
Michael DooleyTrialHub, Alfred Health, Melbourne, Victoria, Australia.
Robert BlumBendigo Health, Bendigo, Victoria, Australia.
Narelle McPheeBendigo Health, Bendigo, Victoria, Australia.
Tricia WrightLatrobe Regional Hospital, Traralgon, Vic, Australia.
Zee Wan WongPeninsula Health, Frankston, Victoria, Australia.
Jacqueline DixonTrialHub, Alfred Health, Melbourne, Victoria, Australia.
Stephen M JaneTrialHub, Alfred Health, Melbourne, Victoria, Australia.
Alfred Health · AUBendigo Health · AULatrobe Regional Hospital · AUPeninsula Health · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: 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: 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: 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: 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.

Indexed as

Delivery of health careHumansRandomized controlled trials as topic/methodsRegionalRural population

Identifiers

PMID36712185
PMCPMC9876817
OpenAlexW4317241437

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.