In order to guide developers of diagnostic tests for the coronavirus strain currently causing a pandemic, the National Institute for Health and Care Excellence (NICE) has launched a framework against which evidence quality can be measured.
“This framework is a 3-stage approach to collecting the best possible data and
evidence in the short and long term, while tests are being quickly developed and
validated during the COVID-19 pandemic.”
The document guides developers through the stages:
- Doing a good diagnostic test accuracy study
- Demonstrating clinical significance
- Developing the value proposition
The information in the Framework is detailed and helpful, and provides a number of general lessons that are of use to any diagnostics development.
Find the framework on the NICE COVID-19 website.