Evidence development pathway for medical tests
New medical tests and devices can provide great advantages to patient care. However, the test developers need to provide evidence to demonstrate these benefits before their technologies can be purchased and adopted by the UK healthcare system.
Medical test developers need to address the following questions:
- In what scenario could the test add the most value? (care pathway analysis and early economic modelling)
- Does the new test produce reliable reproducible results in the laboratory? (analytical validity)
- How does the new test compare with current tests that are used in healthcare? (clinical validity)
- What are the benefits to patients if the new test is used? (clinical utility)
- What is the economic impact of using the new test? (health economics)
We provide independent methodological expertise to help the developers of new in vitro diagnostic tests to generate this evidence. Our team of six methodologists, led by two senior methodologists, are focused on the design and analysis of:
- Care pathways
- Health economics
- Studies to demonstrate clinical validity and clinical utility
We can help to identify research questions that test developers might not have considered. Results from these studies can inform plans for future evidence development and the developer’s strategy for UK adoption.
You can read more about our framework for evidence development and its benefits to test developers by following this link.