The severity assessment landscape is not always easy to navigate, scales developed for illustrative purposes, or a particular project have found their way into future research projects simply due to a lack of a more appropriate alternative.
Many indications in the immuno-dermatology therapeutic area, have no validated scales or even no formal instruments at all.
The process of scale development has always been labor intensive and time consuming. The management of the process, requiring input and feedback from an expert committee as well as formal consensus and testing, is followed by thorough statistical analysis to demonstrate scale reliability.
Sponsors who recognize a deficiency in scoring tools usually do not have time to develop a suitable instrument on a study timeline, neither do most trial managers have scale development and validation experience. This is where we can help.
TRI has extensive experience supporting the development and validation of severity scales.
- Organizing Committee meetings to define severity descriptions
- Provide or source photos for morphological disease examples
- TAVOS™ platform automates consensus exercises, photo validation & selection
- KAPPA statistic calculation to measure reliability