Demystifying Goal Attainment Scaling: Personalized Endpoints in FDA Patient-Focused Drug Development

Patient Reported Outcome Measures (PROMs) are increasingly included in clinical development research to capture the patient experience. In April 2023, the US Food and Drug Administration (FDA) published the patient-focused drug development draft Guidance 4, Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making. This guidance outlines the potential value of personalized endpoints, such as Goal Attainment Scaling (GAS), in capturing meaningful change.

The webinar will introduce Goal Attainment Scaling, including its use history and applications throughout the clinical development lifecycle. The discussion will also include practical considerations for the standardized implementation of GAS in clinical development. Finally, the featured speakers will address the strengths and weaknesses of Goal Attainment Scaling as articulated in the FDA draft Guidance 4.

Watch this webinar to learn about the applications of Goal Attainment Scaling in patient-focused clinical drug development.