WS3: Assessing Assessment Methodologies: Weighing Choices Based on Indications, Study Design and Needs

Chairs: Michael Davidson, MD; Michael Detke, MD, PhD

The increasing number of failed trials and unexpected negative results have raised the need to re-visit assessment methodology both in terms of study entry criteria and of ongoing severity assessments. Reducing the number of raters, better raters training, videotaping and reviewing ratings, use of patient-reported outcomes in various ways, and centralized rating have been proposed and utilized as alternatives to the traditional ratings. In this workshop we will discuss strengths and limitations of each, applicability to indications, and study designs.  There will be a particular emphasis on data addressing how reliable and valid the alternatives are, and whether they improve drug-placebo signal or reduce placebo response relative to traditional site-based ratings.  The discussion will focus on gaps in the existing data and future studies that are needed.