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Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments
Session Chair(s)
Lisa A 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)
Rima Izem, PHD
Associate Director Statistical Methodology, Novartis, Switzerland
Panelist
Cheryl Coon, PHD
VP, Clinical Outcome Assessment Program, Critical Path Institute, United States
Panelist
Laura Lee Johnson, PHD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
Panelist
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