Teletrials - Clinical Trials and Research

Background

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.

What is a teletrial?

Teletrials are a new model for conducting clinical trials. A teletrial is a group of health service organisations clinical trial sites that work together to conduct a clinical trial under the supervision of a Principal Investigator at the Primary site. A cluster is a group of two or more sites conducting the same trial. Through various telecommunication methods between the Primary site and Satellite site(s), the model enables the delivery of clinical trials closer to home for patients, particularly in regional, rural and remote locations.

A Principal Investigator at the Primary site, is responsible for the trial and supervises the Associate Investigator/s at the Satellite site/s

What are the additional requirements for a teletrial?

A Supervision Plan which outlines processes for a Principal Investigator at the Primary site in the supervision of any study-related duties and functions conducted at a Satellite site. Site-specific Supervision Plans are developed and submitted to the Primary site Research Governance Office and the relevant Research Governance Office for each Satellite site governance application. A Teletrial Supervision Plan template is available on the Australian Teletrial Program (ATP) webpage under the resources tab. In addition, an educational video is available with guidance on completing the 'Teletrial Supervision Plan' template. A Teletrial Supervision Plan – HREC Information Sheet is also available (under the resources tab) for reviewing Human Research Ethics Committees with a summary of activities that is considered in a Supervision Plan
Delegation Log required by ICH GCP for all Satellite sites regardless of experience.
A Head Agreement (Clinical Trial Research Agreement) between the Sponsor and the Primary Site.
Teletrials Sub-Contract between the Primary Site and the Satellite Site Institutions.
The Clinical Trial Research Agreement (CTRA) for Investigator-Initiated Teletrials where the Institution is acting as the Sponsor and the Other Institution acting through Satellite Site/s is available for Victoria only.

The Australian Teletrial Program (ATP)

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.

ATP guidance

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:

The National Standard Operating Procedures for Clinical Trials, including Teletrials in Australia
The National Principles for Teletrials in Australia

The National Standard Operating Procedures will help organisations to standardise their procedures for clinical trials.

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
Delegation Log template is 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.

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.

Teletrial Support Program-Program Areas

To fulfil the objectives of the TSP, two program areas have been identified, TSP- Program 1- Startup Package Initiative and TSP Program 2- Recruitment Boosting Support.

Both programs support Primary and Satellite Sites to achieve the objects of the ATP including expanding the reach of clinical trials to rural regional and remote patients in Victoria and closing the gap in health outcomes for all Victorians.

Further information can be found in the ATP-VIC Supplementary Information document which outlines the program areas, eligibility and the application process for the TSP funding in Victoria.

Registry-Based Studies-Expansion

Eligible non-interventional registry-based studies, conducted using the teletrial methodology in Victoria, may qualify under certain circumstances for a Start-Up Support Package. This Victorian only initiative is intended to support workforce development, build research infrastructure, promote collaboration and networking between sites and foster the creation of interconnected clusters, ensuring they are well-prepared for future teletrials. This expansion is only for registry-based studies and does not extend to observational studies.

Further information can be found in the ATP-VIC Supplementary Information-Addendum document.

To be considered and qualify for the Start-Up Support Package for non-interventional registry-based studies, a Registry-Based Studies Capacity and Capability Assessment Form must be completed and submitted to RCCC@safercare.vic.gov.au.

Teletrial Equipment Funding Initiative

The Teletrial Equipment Funding Initiative supports capability development at regional, rural and remote health services in Victoria. The initiative provides funding to eligible sites to address gaps in clinical trial equipment, enabling them to attract and support the conduct of quality teletrials.

Further information can be found in the Teletrial Equipment Funding Initiative document which outlines the initiative object and eligibility criteria.

To be considered for Equipment Funding Support, applicants must complete and submit an Equipment Funding Expression of Interest form to RCCC@safercare.vic.gov.au.

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 C. 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 rccc@safercare.vic.gov.au

For further enquiries contact the RCCC-VIC at 0499 810 778