Enhancing rural and regional access to clinical trial using the Australasian Teletrial Model (ATM): Experience from MonarchE adjuvant breast cancer trial in Queensland, Australia.

7 Background: Australasian Teletrial Model (ATM) was developed in Australia to enhance rural and regional access to clinical trials using Telehealth. Under this model, trial clusters are established by connecting smaller satellite centers with larger primary sites using telehealth; governed by standard operating procedures and streamlined approval and contractual processes recently developed by the department of health of state of Queensland. Principal Investigator oversight and roles and responsibilities of sites are documented on supervision plans. We describe the implementation of an Eli Lilly’s adjuvant breast cancer trial MonarchE using ATM in Queensland. Methods: Two larger trial sites as primary sites were linked to four smaller centres to form Northern and Goldcoast clusters. This is a descriptive study of implementation research including perspectives of clinical trial staff. Results: Between February 2018-Feb 2019, four new sites and eight new satellite staff acquired clinical trial capabilities locally. Site initiation and regular trial meetings within clusters were conducted via telehealth. 11 patients were enrolled at satellite sites. No protocol violations occurred at any of the sites including documentation and investigator product handling. Staff (six trial nurses, and 10 medical oncologists) welcomed the model for facilitating inter-site collaboration and enhancing trial access to patients. Eli Lilly incurred additional cost for conducting one-off site visits to satellites and managing medication transport to satellites. Staff spent additional time for cluster coordination and development of new processes. Conclusions: Regional sites and their staff can acquire capabilities to offer clinical trials locally using the teletrial model. Consequently, rural patients can gain access to clinical trials closer to home without needing to travel long distances. Staff welcome this model for its many benefits to patients and the system. Initial increase in set-up cost is likely to be offset by better recruitment rates. With maturity, set-up costs and time to coordinate cluster processes are likely to lessen.