Analysis of composite scores in clinical trials



Greater Copenhagen area

Background: In some clinical trials, one makes a series of assessments in roughly similar areas. For example, in cognition (referring to various brain processes) the measurements refer to the ability to perform various tasks. One approach is then to analyze each task separately as a reflection of the capabilities needed for that specific task. An alternative approach is to make some sort of joint analysis (for example, a summed or weighted combination) and the results should then be considered as an overall assessment of cognition. A joint analysis requires some choices; such as: how to combine the individual measurements to give an adequate reflection of the overall cognition; what to do if a single measurement is missing. The interpretation of the results also requires consideration of the possibility that a treatment influences only a subset of the brain processes needed for the various tasks.


The project consists of analyzing results from existing Lundbeck clinical studies within depression using several of the potential methods and based on this, as well as theoretical considerations, discuss the best analysis strategy.

Potential methods could e.g. be factor analysis, structural equation models and methods for missing data.

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