ABSTRACT
This chapter reviews the development and validation of computerised clinical assessments for use in clinical trials. ePRO solutions have the unique ability to make novel measurements and also to assimilate complex data The chapter focuses on use of computerised methods to make subjective assessments normally confined to an expert rater or an investigator. Much of the key work performed to date in this area relates to the assessments made in the Central Nervous System (CNS) area, and in particular the measurement of severity and diagnosis of depression and anxiety. The chapter reviews key validation studies demonstrating the equivalence of computerised assessments to clinician-made subjective assessments, with particular focus on the Hamilton Depression and Anxiety rating interviews. It also reviews the results of studies using these techniques, illustrating their particular utility in limiting the potential for inclusion bias in CNS clinical trials and providing particularly sensitive measures of change.
