What is a teletrial?
A teletrial uses telehealth technology to communicate between the Primary Site and Satellite Site/s and enable delivery of aspects of a clinical trial as defined in the Supervision Plan. This technology supports a Principal Investigator to supervise Associate Investigator/s to conduct a clinical trial at a Satellite Site which is geographically remote from the Principal Investigator’s Primary Site. The Principal Investigator remains responsible for the trial. A detailed Supervision Plan is required, in addition to a Delegation Log required by ICH GCP for all Satellite Sites regardless of experience. Trial participants may have trial visits at both the Primary and Satellite Sites, as determined by the Protocol and Supervision Plan. The conduct of the trial is detailed under the ‘head agreement’ (Clinical Trial Research Agreement/Clinical Trial Agreement) between the Sponsor and the Principal Investigator’s Institution and a Sub-Contract between the Primary Site and the Satellite Site Institutions (see Clinical Trial Research Agreement - Tele Trials Subcontract) for sites external to Queensland Health, and this version between Queensland Health sites only).
Core principles of teletrials
- increase access to clinical trials by rural, regional and remote communities, including Indigenous communities
- develop collaboration between rural, regional, remote, Indigenous communities and metropolitan centres, and between tertiary centres across the state
- deliver a greater engagement in research activity
- improve the rate of recruitment of patients into clinical trials across the state and nationally
- reduce the disparity in patient outcomes for geographically dispersed populations
- build clinical trial capacity and provide clinical trial related training to our workforce with the aim of increasing the number of “trial ready” sites in the State and upskilling rural, regional and remote workforce.
Benefits for patients
Through teletrials, patients can be seen closer to home leading to:
- participation in a clinical trial with family, community and local healthcare support;
- a reduction in travel and accommodation costs;
- equity of access for all Australians to clinical trials and improved access to potential new therapies.
The Clinical Oncology Society of Australia (COSA) established the Australasian Teletrial Model in September 2016. In 2018, Queensland Health piloted this model to evaluate the impact it had on sponsors, sites and participants. The pilot included the first successful Australian commercial clinical trial conducted as a teletrial between Queensland Health and Eli Lilly Australia.
Subsequently, Queensland Health and the Commonwealth Department of Health, through the Clinical Trial Project Reference Group (CTPRG) agreed to roll out the teletrial model nationally.
The National Teletrials Compendium has been agreed to by all states and territories and supports a national approach to teletrials. It consists of two publications:
- National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia
- National Principles for Teletrials in Australia