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戻る Agenda
Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments
Session Chair(s)
Lisa Kammerman, PhD, MS
Regulatory Statistics and PRO Consultant
Kammerman Consulting, LLC, United States
Challenges faced by those who evaluate the results of randomized controlled trials that are designed to evaluate the performance of new clinical outcome assessments are discussed. Strategies beyond psychometric validation techniques are identified.
Learning Objective : Identify clinical outcome assessment (COA) properties that should be evaluated in a phase 2 randomized clinical trial prior to the COA’s use in a phase 3 trial; Discuss classical and modern psychometric methodology limitations to evaluating COAs used in medical intervention trials; Describe other approaches that can be used to evaluate some of these properties.
Speaker(s)
Panelist
Rima Izem, PhD
Novartis, Switzerland
Associate Director Statistical Methodology
Panelist
Cheryl Coon, PhD
Critical Path Institute, United States
VP, Clinical Outcome Assessment Program
Panelist
Laura Lee Johnson, PhD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER