‘The time for experimenting on patients is over’: a policy scan and qualitative study of doctors’ experience with the oversight of clinical innovation in Australia

Objectives Clinical innovation – the use outside of research of novel and unproven interventions – is subject to extensive federal and state oversight in Australia. Although the complexity of the regulatory environment is widely recognised, there have been no attempts to identify and summarise the policies governing clinical innovation or to understand how Australian clinicians navigate this environment. This study addresses these gaps by mapping the oversight of clinical innovation in Australia and exploring clinicians’ experiences to understand practical challenges and identify opportunities for improvement. Methods A policy scan of publicly available documents was conducted between 2020 and 2025, and a qualitative interview study undertaken. Participants included surgeons, cancer physicians and fertility specialists who were recruited using purposive and snowball sampling from Australian states and territories. Results The policy scan revealed complicated oversight mechanisms across multiple jurisdictional levels, with both overlap and variation in regulatory approaches between states and territories. Participants described the practical challenges of navigating this complex system while highlighting the importance of peer support, training and long-term outcome monitoring as key mechanisms for supporting responsible clinical innovation. Conclusions States and territories have developed fragmented, duplicative and sometimes opaque oversight mechanisms, creating unnecessary complexity and potential gaps in coordination. To improve the oversight of clinical innovation in Australia, a national framework is required that establishes clear processes for the introduction of innovative interventions while permitting jurisdictional modifications in local contexts.