CLINICAL TRIALS AND RESEARCH

Teletrials

    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. A Teletrial Supervision Plan – HREC Information Sheet is also available 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 Multisite Clinical Trials v Teletrials Matrix outlines specific details and compares teletrials with multisite trials.

    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:

    Other documents include:

    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.

    Further information can be found in the Teletrial Support Program Guidelines and the ATP-VIC Supplementary Information document which outlines the application process for the TSP funding in Victoria.

    How to register a trial under the ATP teletrial model

    There are two pathways:

    1. 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.
    2. 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

    pdf
    ATP Teletrial Support Program-ATP-VIC Supplementary Information_(May 2024)
    (PDF File - 383.3 KB)
    May-2024
    pdf
    Evaluation of a site as a Satellite Site checklist
    (MS Word Document - 160.3 KB)
    Apr-2024
    pdf
    Evaluation of a trial as a teletrial checklist.docx
    (MS Word Document - 157.3 KB)
    Apr-2024
    pdf
    Multisite Clinical Trials v Teletrials Matrix
    (PDF File - 231.8 KB)
    Apr-2024
    pdf
    Primary Site Workflow checklist
    (MS Word Document - 158.6 KB)
    Apr-2024
    pdf
    REDCap, TSP process summary and PICFs_April 2024
    (PDF File - 269.7 KB)
    Apr-2024
    pdf
    Teletrial Registration Form
    (MS Word Document - 142.8 KB)
    Apr-2024
    pdf
    Teletrial Support Program Guidelines
    (PDF File - 273.3 KB)
    Nov-2023