2012 Autumn: Clinical Trials in Autism Spectrum Disorders: Methods, Measurements, Designs and Outcomes

Co-chairs: Douglas Feltner, MD; Joseph Horrigan, MD

This session will provide an overview of the progress toward new treatments for  Autism Spectrum  disorders (ASD). The characteristics of the disorders will be reviewed, along with impending changes in DSM-V and their impact on subject selection and outcome measurement. Results from recent clinical trials will be presented, along with insights into the challenges of designing and running clinical trials for these disorders.  Methods of clinical measurement for use in early and late phase development will be discussed. Established regulatory precedents will be reviewed along with areas of regulatory uncertainty.