You have a plan for a clinical trial… 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 patients, community and/or 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.

Funding bodies increasingly seek to understand the ‘return’ on their investment in research, so you need to consider how to measure the impact of your clinical trial before it starts, as it is often not feasible or affordable to collect the necessary data retrospectively.

• A research Impact statement can help you and funding bodies identify if your research idea is valid and worth the investment of time and money.
• Consider what needs to be included in the design of your trial so that you can assess its affordability, value and improvement in patient care or outcomes, if your idea was to become implemented into routine healthcare.

• Can you add value to your clinical trial by having participants report on relevant quality of life measurements at different time points in the trial?

Who can help?

• HMRI Research Impact and Evaluation team foster the integration of economic principles and techniques into health research, build regional capacity and expertise in health research economics and to conduct original research of relevance to the field of health economics.
  • Their ‘FAIT’ model is a novel framework specifically developed to encourage research translation and measure and report on research impact in a multi-dimensional way.
• Ensure you involve your consumer representatives in the development of the impact measurements. Patient reported measures {Glossary, new definition ‘Patient reported measures’} – both outcomes and experiences – are important in persuading decision makers to change policies and procedures.
• You can also measure the impact of your consumer involvement activities. The Australian Health Research Alliance (AHRA) has assessed publicly available tools to help measure the Impact of Consumer and Community Involvement in Health Research.
• GRIPP2  is an international checklist for reporting on consumer involvement in research.