**2. Core principles of the tele-trial model**

The core principles of the tele-trial model are as follows:


**2.1. Anticipated benefits**

**Figure 4.** A tele-trial cluster.

Similar to tele-health models for delivering routine cancer care, there are a range of benefits associated with conducting clinical trials using tele-health strategies. Modern informatics supporting technological advancements in communication enable a greater depth of reach to more Australians. Notably the tele-trial model has the potential to make clinical trials accessible to people with cancer from rural and remote centres closer to home. Increasing accessibility for increased participant recruitment may also improve collaboration and networking between rural and metropolitan centres, provide workforce development, facilitate engagement in research activity for improved adherence with guideline recommended care and

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reduce the disparity in cancer outcomes for geographically dispersed populations.

There is a second related benefit of the model for Australia's geographic reality, and comparatively small population for which tele-trials may provide a useful solution. This benefit relates to the complexity and innate molecular and phenotypic heterogeneity of cancer. That is, any one tumour type is actually made of multiple discrete subgroups. Hence, trials requiring the eligible population to have a similar tumour subtype in order to compare two different interventions are more and more difficult to conduct. Increasingly, these studies involve numerous centres around Australia or indeed internationally. The corollary of such an observation is that individual centres, even large tertiary referral centres will only see a very small number of patients whose tumour fits the eligibility criteria for these studies in any one year. As the cost of establishing and maintaining the infrastructure to open poorly recruiting studies is so high, such centres are becoming increasingly reluctant to open these studies in the first place. Consequently, these studies recruit even fewer patients overall than might reasonably be expected because the only trial site(s) recruiting to one of these studies is geographically distant from the potential participant. Another advantage is workforce development. Exposure to, and involvement in research provides professional development opportunities through collaboration with leading clinical

**3.** To articulate the relationship between the primary site and satellite site as a trial cluster. The trial cluster co-ordinates the trial across multiple sites including a primary site and one or more satellite site(s), ideally through streamlined trial processes (**Figure 4**). A trial cluster may exist in the following settings: (a) larger metropolitan centres as primary sites with other metropolitan centres as satellites even within the same city; (b) larger metropolitan centres or large regional centres as primary sites with smaller regional or rural sites as satellites; or (c) larger regional centres as primary sites with metropolitan centres as satellites in an attempt to improve the capabilities and community profile of regional centres.

**Figure 3.** Australasian teletrial model. Adapted from Sabesan and Zalcberg [21].

**Figure 4.** A tele-trial cluster.

**2. Core principles of the tele-trial model**

contracted (**Figure 3**).

160 Clinical Trials in Vulnerable Populations

The core principles of the tele-trial model are as follows:

trial capacity, and providing trial-related training.

**Figure 3.** Australasian teletrial model. Adapted from Sabesan and Zalcberg [21].

**1.** To increase accessibility to trials thereby reducing the need for people with cancer to travel to larger centres to attend study-related visits and undertake study-related procedures. Using tele-oncology models, there is an opportunity for patients from rural or regional sites to be recruited, consented, and treated, and to attend follow-up visits—a hub-andspoke approach between a primary trial site and a satellite site. The roles and responsibilities for each site need to be clearly defined at the outset of each trial and appropriately

**2.** To develop collaboration and networking between regional/rural and metropolitan centres and between tertiary centres even within the same metropolitan setting with the aim of delivering greater engagement in research activity, improving adherence to evidencebased practice, improve the rate of recruitment of patients into clinical trials, reducing the disparity in cancer outcomes for geographically dispersed populations, building clinical

**3.** To articulate the relationship between the primary site and satellite site as a trial cluster. The trial cluster co-ordinates the trial across multiple sites including a primary site and one or more satellite site(s), ideally through streamlined trial processes (**Figure 4**). A trial cluster may exist in the following settings: (a) larger metropolitan centres as primary sites with other metropolitan centres as satellites even within the same city; (b) larger metropolitan centres or large regional centres as primary sites with smaller regional or rural sites as satellites; or (c) larger regional centres as primary sites with metropolitan centres as satellites in an attempt to improve the capabilities and community profile of regional centres.

#### **2.1. Anticipated benefits**

Similar to tele-health models for delivering routine cancer care, there are a range of benefits associated with conducting clinical trials using tele-health strategies. Modern informatics supporting technological advancements in communication enable a greater depth of reach to more Australians. Notably the tele-trial model has the potential to make clinical trials accessible to people with cancer from rural and remote centres closer to home. Increasing accessibility for increased participant recruitment may also improve collaboration and networking between rural and metropolitan centres, provide workforce development, facilitate engagement in research activity for improved adherence with guideline recommended care and reduce the disparity in cancer outcomes for geographically dispersed populations.

There is a second related benefit of the model for Australia's geographic reality, and comparatively small population for which tele-trials may provide a useful solution. This benefit relates to the complexity and innate molecular and phenotypic heterogeneity of cancer. That is, any one tumour type is actually made of multiple discrete subgroups. Hence, trials requiring the eligible population to have a similar tumour subtype in order to compare two different interventions are more and more difficult to conduct. Increasingly, these studies involve numerous centres around Australia or indeed internationally. The corollary of such an observation is that individual centres, even large tertiary referral centres will only see a very small number of patients whose tumour fits the eligibility criteria for these studies in any one year. As the cost of establishing and maintaining the infrastructure to open poorly recruiting studies is so high, such centres are becoming increasingly reluctant to open these studies in the first place. Consequently, these studies recruit even fewer patients overall than might reasonably be expected because the only trial site(s) recruiting to one of these studies is geographically distant from the potential participant.

Another advantage is workforce development. Exposure to, and involvement in research provides professional development opportunities through collaboration with leading clinical researchers. This may have flow-on benefits for improved access to trials and improved quality of care. There are also advantages for Australia to develop a more flexible approach to the conduct of trials; given our relatively small population and geographic barriers to recruitment. Recruiting specific patient cohorts is an ever-present challenge. Without multisite collaboration, Australia is less attractive to international trial Sponsors, which limits the availability of experimental, life-saving treatments. Developing these clinical trial networks through models like this tele-trial concept, we can better promote our capacity to support a wider range of trials.

nursing, allied health, pathology and pharmacy research capabilities. Site capacity and trial complexity will determine the ability of the site to conduct trial-related activities at the satellite site and will be assessed by the Sponsor at the time of site selection. It is not anticipated the satellite site will undertake all trial-related activities. Satellite sites that have established trial capabilities are able to take part in complex protocols from the outset. At sites that have no or limited experience in delivering clinical trials, a staged approach may allow for gradual

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For sites that have not taken part in clinical trials previously, as required under current practice, it is likely that the Sponsor may wish to perform a site visit. The Sponsor may also wish

Some registration bodies require that the primary site Principal Investigator (PI) take responsibility for overall supervision of the trial across a cluster. Tele-health offers a unique opportunity for direct supervision of patient management. A supervision plan agreed between the primary and satellite sites and the Sponsor needs to be developed and formalised at the outset of a trial. The supervision plan may include, but not be limited to, details on joint consultations using tele-health, collation and monitoring of documents, frequency of joint trial meetings across a cluster (with minutes of these meetings) and any site visits performed by the PI.

While the travel by staff and patients is reduced as the result of this model, Sponsors may wish to undertake site visits for accreditation and monitoring purposes, unless remote monitoring is agreed by the Sponsor and source documents are available at the primary site.

The workforce requirements of current tele-health models could be extended to the tele-trial model. While larger rural and regional centres may have resident or visiting medical oncologists, oncology clinicians and trial nurses, satellite sites may have limited specialised services. Under the current tele-health models, urban specialists at a primary site provide their services using videoconferencing. Service delivery is supported and facilitated by doctors, nurses and allied health professionals at a satellite site. The nature of support to and by the rural health professionals would be determined by the complexity of the trial and the clinical capabilities at the site [22, 23]. The delegated responsibilities would need to be agreed by the Sponsor, clearly documented within the master site file and trial-related training records provided

Defining roles and allocating specific responsibilities to staff within a cluster can ensure the safe and efficient conduct of clinical trials. The satellite team would need to take part in the Investigator Meeting & Study Initiation Visit so that they are fully aware of the requirements

building of clinical trials capacity from simple to more complex trials.

*3.1.1. Accreditation of satellites*

*3.1.2. Supervision plan*

*3.1.3. Site visits*

to delegate this responsibility to the primary site.

**3.2. Workforce: roles and responsibilities**

before this delegation could occur.

Tele-trials offer the unique opportunity to impact this inevitable cascade of circumstances that compound the difficulties of defining new treatments for so many cancers in the modern era of molecular characterisation of cancer across regional and rural Australia.

#### **2.2. Anticipated costs and threats**

While the benefits discussed above have positive flow on effects on patient care and the Australian Health system as a whole, system improvement using this model is unlikely to be achieved without added cost for the sponsors (including increased site visits, medication transport cost to satellites, etc.), hospitals and governments (increased workforce, technological and pharmacy infrastructure). Benefits of improved rural access to clinical trials and enhanced rate of recruitment can offset those extra costs. Reforms on remote monitoring, site accreditation, ethical, governance and contractual processes are required at a system level to reduce financial and human resource cost.

Geographic isolation due to distance may cause several problems including workforce stability, transporting and handling of medications and devices, access to source documents and communication between sites which can be mitigated by implementing the processes outlined in this document.
