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A capability framework to inform the fundamental requirements for clinical trial unit development, growth and long term success in outer metropolitan and rural areas.
Woollett, Anne; Duncan, Jhodie; Voskoboynik, Mark; Shackleton, Mark; Dooley, Michael; Blum, Robert; McPhee, Narelle; Wright, Tricia; Wong, Zee Wan; Dixon, Jacqueline; Jane, Stephen M.
Afiliación
  • Woollett A; TrialHub, Alfred Health, Melbourne, Victoria, Australia.
  • Duncan J; Latrobe Regional Hospital, Traralgon, Vic, Australia.
  • Voskoboynik M; TrialHub, Alfred Health, Melbourne, Victoria, Australia.
  • Shackleton M; Central Clinical School, Monash University, Melbourne, Victoria, Australia.
  • Dooley M; TrialHub, Alfred Health, Melbourne, Victoria, Australia.
  • Blum R; TrialHub, Alfred Health, Melbourne, Victoria, Australia.
  • McPhee N; Bendigo Health, Bendigo, Victoria, Australia.
  • Wright T; Bendigo Health, Bendigo, Victoria, Australia.
  • Wong ZW; Latrobe Regional Hospital, Traralgon, Vic, Australia.
  • Dixon J; Peninsula Health, Frankston, Victoria, Australia.
  • Jane SM; Faculty of Medicine, Nursing & Health Science, Peninsula Clinical School, Monash University, Melbourne, Victoria, Australia.
Contemp Clin Trials Commun ; 32: 101072, 2023 Apr.
Article en En | MEDLINE | ID: mdl-36712185
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: Contemp Clin Trials Commun Año: 2023 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Prognostic_studies Idioma: En Revista: Contemp Clin Trials Commun Año: 2023 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Países Bajos