Clearing the pathway for global clinical trials

This explainer sets out barriers to, and proposed solutions for, increasing commercial clinical trial activity in Australia, while noting that many of the improvements would also benefit non-commercial trials. It argues that uncoordinated state-based systems and inefficient processes add to the cost of trials and limit Australia’s potential as a preferred global trial destination. Seven reform areas are proposed: a national approach to decentralised clinical trials and teletrials; a genuine one-stop-shop for ethics and governance approvals, building on National Mutual Acceptance; updating the IHPA standard costing tool, which has not been updated since 2015; a nationally agreed framework for reporting trial performance, including compulsory reporting to the ANZCTR; linking health data such as MBS, PBS and My Health Record data to trial recruitment and feasibility; strengthening the clinical trials workforce, particularly clinical trial nurses; and greater consumer involvement, including PREMs and PROMs. A stage-by-stage diagram maps barriers and solutions from funding through to outcomes, and the paper summarises existing reforms it seeks to build on, including the $614 million MRFF 10-year clinical trial program and $125 million for rural and remote trials.