The Australasian Teletrial Model was developed by the Clinical Oncology Society of Australia (COSA) to increase access to clinical trials for people living in rural and remote locations. The Australasian Tele-Trial Model is described in detail to access clinical trials closer to home using tele-health.
What is a teletrial?
A teletrial uses telehealth technology to conduct all or part of a clinical trial at a Satellite Site under the supervision of a Primary Site. A Principal Investigator, at the Primary Site, is responsible for the trial and supervises the Associate Investigator/s at the Satellite Site/s. There may be multiple Satellite Sites associated with a Primary Site, referred to as a 'cluster' of Satellite Sites.
The Multisite Clinical Trials v Teletrials Matrix outlines specific details and compares teletrials with multisite trials.
The Australian Teletrial Program (ATP)
Teletrials uses telehealth to connect clinical trials to regional and rural areas by setting up Satellite Sites and connecting these to a Primary Site clinical trial. This has potential to extend clinical trials into rural and regional Victoria through funding from the Commonwealth Government.
The Australian Teletrial Program is supported by funding under the Medical Research Future Fund. The Program has been funded $75.2 million over five years (from 2021-22 to 2025-26) to bring clinical trials closer to home for patients in Queensland, Victoria, Tasmania, South Australia, Western Australia and Northern Territory.
Queensland Health lead the ATP and has formed a National Office to guide the program to achieve a harmonised approach with state and territory collaborators to bring clinical trials and teletrials closer to home for rural, regional and remote communities across Australia.
The ATP may apply to Victorian public or private health services, day procedures service or public dental practice accredited to the National Safety and Quality Health Service (NSQHS) Standards or be an accredited General Practice.
Delivering clinical trials through a teletrial closer to the home of a participant has the potential to address equity of access to trials for rural, regional and remote patients. Benefits for participants could include reduced travel and cost; having treatment with family, community and local health care support; and delivering better health outcomes for all Victorians.
The Australian Government, Department of Health and Aged Care has supported the development of the National Teletrials Compendium to enable a national approach to teletrials and consists of two publications:
- National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia
- National Principles for Teletrials in Australia
The National Standard Operating Procedures will help organisations to standardise their procedures for clinical trials. A Supervision Plan and Delegation Log for teletrials are included in appendices 4 and 5.
The ATP National Office has developed resources when considering a trial with a teletrial component for participating jurisdictions. The following documents are based on the ATP version for use in Victoria.
Key documents required to enable conduct of the trial under the ATP include the following:
- Primary Site Workflow checklist
- Supervision Plan and Delegation Log templates are recommended in the National Teletrials Compendium
- Participants Information and Consent Forms available for use in teletrials:
- Standard template for an Interventional Study for use when a trial is intended to be conducted as a teletrial from the outset.
- The Stand Alone Teletrial PICF for use for an already approved trial and some sites will be added as teletrial sites.
- A Stand Alone Teletrial PICF for Person Responsible\Medical treatment decision maker is also available for use.
If every participating site is converting to a teletrial, the approved Master PICF is amended to include the teletrial wording as provided in the Standard template for an Interventional Study.
Other documents include:
- A Research Governance checklist which includes the governance requirement for teletrials
- Clinical Trial Research Agreement (CTRA) available on the Medicines Australia website, Clinical Investigation Research Agreement (CIRA) available on the Medical Technology Association of Australia website or other 'head agreement' between the trial sponsor and the Principal Investigator's institution
- A CTRA TeleTrial Subcontract between the Primary Site and a Satellite Site available on the Medicines Australia website.
Teletrial Support Program
The Teletrial Support Program (TSP) provides funding support for clinical research teams to participant in the Australian Teletrial Program so that sites can be supported to expand clinical trials through the teletrial model.
The funding program seeks to:
- Support clinical trial sites in expanding clinical trial activity to rural, regional and remote sites.
- Support clinicians in rural, regional and remote areas to offer clinical trial participation locally through teletrials.
- Support researchers and potentially provide additional resources to increase recruitment of participants and meet recruitment targets sooner.
The TSP is open to eligible teletrials from 09 November 2023 to 04 October 2026.
How to register a trial under the ATP teletrial model
There are two pathways:
- Victorian regional hubs with ATP database access as outlined in the ATP-VIC Supplementary Information document Appendix B. For further guidance refer to the REDCap , TSP process & PICF document.
- Other teletrials are registered by emailing the completed Teletrial Registration Form to Regional Clinical trial Coordinating Center-Victoria (RCCC-VIC) at email@example.com
For further enquiries contact the RCCC-VIC at 0499 810 778