This Module will discuss ways in which qualitative research is used to select, develop, modify or validate a COA. The amount of qualitative research study teams need to conduct can depend on how much qualitative research for the concept of interest in the context of use is already publically available. Qualitative research is often an initial step health authorities such as FDA mandate when they evaluate the suitability of existing and newly developed COAs selected for a clinical trial

This Module will discuss some of the common quantitative methods used when selecting, developing, modifying and validating a COA. This will include a background to psychometrics and the different properties that are considered for classical test therory and item response theory. It will also touch on the important topic of evaluating change in a COA, what that change means and methods to establish what threshold in the COA of interest would be described as meaningful from the patient's point of view

This module will provide an understanding of a how patient reported outcomes (PROs) are used to measure treatment related tolerability, with a focus on a commonly used measure called the PRO-CTCAE as well as common COA outputs and considerations when interpreting COA data