Graffini Jenna, Johnston Karen, Farrington Alison, McPhail Steven M, Larkins Sarah
College of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia.
Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, QLD, Australia.
Health Res Policy Syst. 2024 Dec 19;22(1):171. doi: 10.1186/s12961-024-01270-z.
Access to clinical trials is limited for rural, regional and remote Australians, adding to the current health inequity between rural and metropolitan populations. The Australasian Teletrial Model was developed to bring clinical trials "closer to home". In 2020, the Australian Teletrial Program was funded to expand and support the uptake of the model across six Australian states and territories. The aim of this study was to explore and describe the clinical trial landscape in Australia prior to the implementation of the Australian Teletrial Program with a particular focus on rural, regional and remote health services.
This qualitative study provides a descriptive exploration of the clinical trial landscape across rural, regional and remote Australia. Data were obtained from semi-structured interviews (n = 33) and one focus group (n = 5) involving clinical trial stakeholders between August 2022 and May 2023. Deductive then inductive thematic analysis used the broad topic areas of the interview schedule as a framework, as follows: education and training, workforce, equipment and services, clinical trial sites, participant recruitment and clinical trial approval process.
This study identified barriers that are generalizable to the Australian clinical trial landscape and those specific to the rural, regional and remote health service context. The main barriers to conducting clinical trials in rural, regional and remote areas were lack of investment and engagement on the part of health service executives, workforce limitations, inconsistent training, lack of physical infrastructure and competing clinical priorities. Despite these challenges, clinicians reported enthusiasm for conducting clinical trials, and opportunities were reported for these health services to partner with larger metropolitan/regional health services, regional universities and communities to support the growth of clinical trial capability and capacity.
The clinical trial landscape in Australian health services varies in terms of quality and availability of training, workforce capacity, executive support, site capability and approval processes. The Australian Teletrial Program has an immense opportunity to overcome some of the reported challenges by supporting capacity and capability building. Ultimately, however, sustainable reform to bring trials closer to home requires a collaborative approach that considers implementation strategies across all levels of the health service and government, alongside other initiatives.
澳大利亚农村、地区和偏远地区的居民参与临床试验的机会有限，这加剧了目前农村和城市人口之间的健康不平等。澳大拉西亚远程试验模式的开发旨在让临床试验“更贴近民众”。2020年，澳大利亚远程试验项目获得资助，以在澳大利亚的六个州和领地推广并支持该模式的采用。本研究的目的是在澳大利亚远程试验项目实施之前，探索并描述澳大利亚的临床试验情况，特别关注农村、地区和偏远地区的卫生服务。
这项定性研究对澳大利亚农村、地区和偏远地区的临床试验情况进行了描述性探索。数据来自2022年8月至2023年5月期间对33名临床试验利益相关者进行的半结构化访谈以及一个焦点小组（5人）。采用演绎法然后归纳法进行主题分析，以访谈提纲的广泛主题领域为框架，如下：教育与培训、劳动力、设备与服务、临床试验地点、参与者招募以及临床试验审批流程。
本研究确定了澳大利亚临床试验普遍存在的障碍以及农村、地区和偏远地区卫生服务背景下特有的障碍。在农村、地区和偏远地区开展临床试验的主要障碍包括卫生服务管理人员缺乏投资和参与、劳动力限制、培训不一致、缺乏物理基础设施以及临床工作重点相互冲突。尽管存在这些挑战，临床医生表示有开展临床试验的热情，并且有报告称这些卫生服务机构有机会与更大的城市/地区卫生服务机构、地区大学和社区合作，以支持临床试验能力的增长。
澳大利亚卫生服务机构的临床试验情况在培训质量和可获得性、劳动力能力、管理人员支持、试验地点能力以及审批流程方面存在差异。澳大利亚远程试验项目有巨大的机会通过支持能力建设来克服一些报告中提到的挑战。然而，最终要实现将试验更贴近民众的可持续改革，需要一种协作方法，该方法要考虑到卫生服务和政府各级的实施战略以及其他举措。
