Novel developments to address methodological issues in Autism Spectrum Disorder

Chairs: L Gault, G Pandina, L Alphs

Despite the relatively high prevalence and lifetime impact of autism spectrum disorder (ASD), wide gaps remain in consistent diagnosis, and identification of meaningful clinical endpoints. This session will clarify the outstanding issues from the perspective of the clinician, the clinical trialist, regulators and advocacy organizations. The goals of this session are to: Discuss heterogeneity of clinical presentation of ASD and the challenges of identifying a suitable population for clinical trials; Identify gaps in identifying meaningful endpoints that adequately track clinically important symptoms and outcomes in persons with autism-spectrum disorder when including them in clinical trials; Identification of regulatory considerations related to clinical trials for autism-spectrum disorder and Identification of opportunities for stakeholders to partner to advance research in ASD