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Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 19, 9:00AM - 10:30AM (Pacific Standard Time)

Session Number:
412

Room Number:
5B

Level:
Intermediate

Type:
Forum

Title:
Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments

Chair(s):
Lisa A. Kammerman, PhD, MS
Senior Principal Scientist
AstraZeneca, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Panelist
Rima Izem, PhD
Lead Mathematical Statistician, Office of Translational Science, CDER
FDA, United States

Panelist
Cheryl Coon
Associate Director, Endpoint Development and Outcomes Assessment
Adelphi Values, United States

Panelist
Laura Lee Johnson, PhD
Statistician, National Center for Complementary & Alternative Medicine (NCCAM)
National Institutes of Health (NIH), United States