1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in Australia in relation to Decentralized Clinical Trials (“DCTs”). Australia abides by the regulations set forth by the Therapeutic Goods Administration (TGA) and also aligns itself closely with certain regulations of the European Medicines Agency (EMA).

There is no definitive evidence to suggest that a fully decentralized trial has yet been conducted in Australia, however hybrid studies have been conducted with an increasing acceptance of decentralized aspects of study design following the COVID-19 pandemic. 

The Australian Government has made further investments in the National Critical Research Infrastructure initiative funded by the Medical Research Future Fund (MRFF) to support Australian health and medical research. The MRFF aims to transform health and medical research and innovation to improve lives, build the economy, and contribute to health system sustainability. Some of the MRFF funding priorities include improving rural, regional, and remote (RRR) clinical trial enabling infrastructure as well as “The Australian Tele-trial Program”, this program provides patient access to clinical trials closer to home, enhances rural and regional access to clinical trials, aid patient recruitment and bring patient centricity to trial design.