Medicines Australia is proud to have been involved in the development of the Australasian Tele-Trial Model, including as part of the funding consortium. The model has been developed by the Clinical Oncology Society of Australia (COSA) Rural and Regional Group in consultation with clinical trial sponsors, clinicians, health administrators and regulatory bodies. While the model was initially designed to increase access to clinical trials for people with cancer living in rural and remote locations, it became apparent that the model was applicable for all clinical trials. This has become particularly significant and achievable through the rapid uptake of telehealth, which will further facilitate clinical trial activity across rural and remote locations.
Developed and piloted over three years, the COSA tele-trials project has demonstrated its proof of concept, including that it can be scaled up nationally for all tele-trials. There are already many patients participating in tele-trials across Australia, including in Queensland, NSW, ACT, Victoria and South Australia.
The following resources have been developed to assist sponsors and sites to establish the Tele-Trial Model:
APJCO supplement Implementation of the Australasian Tele-Trial Model: Lessons from Practice
- Supervision Plan Templates
- Checklist to establish a Tele-Trial cluster for Sponsors and Sites
- Checklist of documents for RGO submission Primary and Satellite Sites
- Post approval steps – teletrial amendments for Sponsors and Sites
- Schedule 2 information for Subcontract June 2018
- Primary Site Q&A Steps to establish the Tele-Trial Model
- Satellite Site Q&A Steps to establish the Tele-Trial Model
- Sponsor Q&A Steps to establish the Tele-Trial Model
- IMP Management in Tele-Trials
- Teletrials Primary Site IMP Handling SOP
- Remote consent process in Tele-Trials
- Sample PICF for Tele Trial Clusters
- Tele-Trials Payment Matrix for Schedule 2
- Tele-trials Frequently Asked Questions
- Primary Site Workload
The VCCC Teletrials Program have also developed a Teletrials Online Learning Module
The National Teletrials Compendium
The compendium consists of two publications, one covers principles and the other covers standard operating procedures for clinical trials and teletrials. The compendium has been agreed to by all states and territories and will help organisations and people who conduct clinical trials.