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Background
Teletrials (TT) are an Australian-conceived clinical trial model using telehealth to improve access to clinical trials [1, 2]. They are a type of decentralised clinical trial (DCT) utilising a supervision plan, to document roles and responsibilities across a network [3]. There is a rapidly growing interest in trial models that support improved equity of trial access in regional and remote areas to improve rural health outcomes [4, 5]. The American Society of Clinical Oncology (ASCO) recommended the use of DCT and TT models beyond the period of lockdowns and US and European regulators issued guidance for the use of digital health in the conduct of clinical trials [6, 7–8]. TT's may be perceived as better suited for use in late-phase trials, due to the lower level of identified risks associated with late-phase trials, coupled with perceived reduced capacity and capability at smaller or more regional clinical trial units. As a result, experts believe that early phase TT are less likely to be considered as a teletrial and there have been limited early phase teletrials implemented to date [9]. To work towards the aim of “all trials being considered as a teletrial”, and a reported rise in the number of early phase clinical trials being conducted in Australia [10], we sought to understand the perceived barriers and enablers that exist to enable a greater uptake of early phase teletrials and for champions to develop an action plan and to advocate for this paradigm shift.
The Victorian Teletrial Collaborative (VTC) is a group of three organisations (VCCC Alliance, Regional Trial Network-Victoria and TrialHub Alfred Health) who have signed a memorandum of understanding and used a collective impact framework to collaborate in an effort to streamline efforts to implement TT in cancer care [11] in coordination with the Australian Teletrial Program [12]. The VTC has hosted two fully virtual national workshops on early phase TT in cancer with national, multidisciplinary representation and the findings from those workshops used to form an action plan are presented.
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National representation
Two workshops were held online in December 2022 and May 2023 and had up to 27 attendees (27 at workshop 1 and 22 at workshop 2) with representation from six of 7 states and territories in Australia. Attendees...