You have a research hypothesis and a clinical trial design, but “so what?” What does your clinical trial mean for patient outcomes and healthcare? It is important to articulate the value of the trial to your patient community and the health district (e.g. new treatment option, safer surgical procedures) through an impact statement.
The Australian Research Council defines research impact as the contribution that research makes to the economy, society, environment or culture, beyond the contribution to academic research.
As funding bodies increasingly seek to understand the return on their investment in your clinical trial it is important that you consider how to prospectively measure the impact of your clinical trial as it is often not feasible or affordable to collect this data retrospectively.