Criteria for Developing and Evaluating Outcome Measures in Clinical Trials
*Nandini Raghavan, Janssen R&D 

Keywords: Endpoint development, Alzheimer's Disease, clinical trials, outcome measures, clinical benefit, statistical criteria

This talk will explore considerations when developing endpoints for clinical trials. We illustrate these ideas using the development of clinical outcome measures for early Alzheimer’s Disease as an example. Critical trial factors such as the population under consideration, the properties of the instruments being considered, as well as the statistical approach used could all impact the selected outcome measure. We further discuss criteria for evaluating outcome measures from both statistical and clinical perspectives, illustrating with examples from available studies.