JMIR Publications

ABSTRACT

The global burden of psychiatric illness continues to increase during this troubling period of industry disinvestment in novel therapies. Reduced assay sensitivity in primary outcome measures has contributed to the exodus of the pharmaceutical industry from the CNS space insofar as it has contributed to late phase failures in major CNS development programs. There are a number of reasons for this reduced assay sensitivity in psychiatry outcome measures including inappropriately broad measures, recall bias, and poor inter-rater reliability. A lack of a more nuanced understanding of how disorders like depression behave also contributes to measurement error in psychiatry clinical trials. We believe that Ecological Momentary Assessment (EMA) or frequent, real time assessment delivered via smart phone will help us overcome these psychometric challenges and prevent late phase failures by increasing the sensitivity of measurement, eliminating recall bias, eliminated bias added by the rater, and finally by producing data that will give researchers a better understanding of how the illnesses we treat behave.