The RWE Navigator Decision Support Tool has been designed to help users understand if and how Real-World Evidence may help to address an issue they may have in developing evidence of the relative effectiveness of a health intervention.
Frequently the intervention will be a new medicine being brought to market, but the tool can be used for older, marketed medicines or to other health technologies.
The Tool has two complementary parts.
- Firstly you are invited to ‘Clarify the issues’ through use of the PICO framework and understanding the drivers for potential gaps between efficacy and effectiveness.
- Once this is complete you can use the tool to ‘Find RWE options’ which links the issues you have identified to RWE study designs and analytical techniques which may be useful overcoming the challenges that you face.
Although the RWE Navigator does not provide you with ready-baked solutions to address the challenges you face, it will hopefully provide you with understanding and insights as to what analyses or studies might be possible and useful. For those interested in detailed methods, you will be pointed towards authoritative sources on best practice in those methods. Where there was a case study undertaken as part of the GetReal project to examine any particular method, you will be directed towards that material to read more about how the method was applied and the views of different stakeholders.
Clarify the issues
This section helps you to gain a greater understanding of the
potential issues (‘effectiveness issues’) in demonstrating the relative effectiveness of a medicine, including actions to explore the
potential issues.
Find RWE options
This section provides different study designs or analytical techniques that may be considered to address the issues (‘effectiveness challenges’), depending on the development stage of a medicine and the relevant PICO category.