IA’s Study Endpoints, Statistics & Data Science, and Clinical Research Communities have formed a Meaningful Change Working Group which aims to help sponsors calculate “meaningful change thresholds” for their clinical trial endpoints, to supplement traditional statistical tests and improve the interpretability of trial data. The ultimate goal is to propose a harmonized approach to, and best practices in, assessing meaningful change in trial endpoints, particularly endpoints evaluated using clinical outcome assessments (COAs) and/or patient-reported outcome (PRO) measures.

This Meaningful Change Working Group has created a survey to evaluate understanding and definitions of meaningful change among regulators, payers, healthcare professionals, sponsors, patients, caregivers, and other healthcare stakeholders. This survey will take about 15 minutes to complete. Your responses are anonymous. Please complete the survey here.