A Multidisciplinary Model for the Governance of Clinical Innovation: Insights From a Qualitative Study of Australian...

Clinical innovation by doctors involves the development and use of interventions that have not been formally evaluated according to the usual standards of evidence-based medicine. While the distinction between research and innovation has been discussed theoretically, little is known about how doctors working in different specialty areas define and understand clinical innovation and how they distinguish it from other related practices. In order to address this gap, this qualitative interview study explored how doctors from diverse specialties defined and understood clinical innovation. Thirty-one semi-structured interviews were conducted with Australian doctors from surgery, reproductive medicine, and cancer care. While participants defined clinical innovation in similar ways, they also identified several morally and clinically salient characteristics that distinguish different types of innovation. Based on these findings, we developed a multidisciplinary governance model for clinical innovation that accounts for its diversity and complexity. This governance model offers clear guidance for determining what types of oversight are most appropriate for different types of clinical innovation. Its benefits include that it can be applied across diverse medical specialties and used alongside existing models, such as those used to identify clinical innovation.