What is a teletrial?
Teletrials are a new model for conducting clinical trials. 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.
Core principles of teletrials
- Increase access to clinical trials for 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 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 with the aim of increasing the number of “trial ready” sites in the state and upskilling rural, regional and remote workforces.
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
- Reduction in travel and accommodation costs
- Equity of access for all Australians to clinical trials and improved access to potential new therapies.
South Australia & Northern Territory Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
The SA Department for Health and Wellbeing has recently established the South Australia and Northern Territory Regional Clinical Trial Coordinating Centre (SA/NT RCCC). The role of the SA/NT RCCC is to:
- Expand and develop clinical trials processes in the six regional Local Health Networks
- Assist in collaboration with participating sites and the establishment of teletrial clusters including assistance with regulatory requirements (sponsor liaison, Human Research Ethics Committee and Research Governance Officer submissions and contract management)
- Provide basic education and training in clinical trials and teletrials
- Identify and provide agreed clinical trials equipment and logistics such as courier transportation of pathology specimens and medication where required.
The SA/NT RCCC is part of the Australian Teletrial Program (ATP) to improve access to, and participation in, clinical trials for rural, regional and remote Australians.
The ATP is funded by the Commonwealth Government’s Medical Research Future Fund – National Critical Infrastructure Initiative, 2019 Rural, Regional and Remote Clinical Trial Enabling Infrastructure grant for the Australian Teletrial Program - access to clinical trials closer to home Project of $75.2M over five years.
V-CTEC – Education and training for people involved in clinical trials in SA
Victorian Clinical Trials Education Centre (V-CTEC) is a new training initiative for everyone involved in clinical trials across South Australia. V-CTEC contains a suite of evidence-based, interactive clinical trials education modules suitable for a range of learning needs. It is available to all staff involved in clinical trials in health services and university settings, regardless of their role or site.
V-CTEC is funded by the SA/NT RCCC and the Office for Research in the Department for Health and Wellbeing and supported by Health Translation SA.
Click here to access V-CTEC training modules.
SA/NT Teletrials Toolkit
- Guidance for Sponsors and Sites
- Quick Guide to Establishing a Teletrial (DOCX 160KB)
- Supervision Plan Templates
- Clinical Trial Research Agreement – Teletrials Subcontract
- National Teletrials Compendium (Including SOPs)
- Evaluation of a clinical trial as a teletrial (DOCX 995KB)
- Evaluation of a site as a satellite site (DOCX 996KB)
- Primary site RGO submission document (DOCX 283KB)
- Satellite site RGO submission document (DOCX 283KB)
- Notification to reviewing HREC of satellite site joining a teletrial (DOCX 194KB)
- Primary Site workflow (DOCX 287KB)
- Satellite Site workflow (DOCX 289KB)
Get in touch
If you are already involved in clinical trials and/or would like to know more about becoming involved in teletrials, please get in touch. We are here to help!
SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC) at SARCCC@sa.gov.au
See the Australian Teletrial Program website for further information about the Australian Teletrial Program.