PNS11 PATIENT-CENTERED METHODS: CONSIDERATIONS FOR QUALITATIVE RESEARCH TO SUPPORT CONTENT VALIDITY WHEN DEVELOPING CLINICAL OUTCOME ASSESSMENT (COA) MEASURES APPROPRIATE FOR ADOLESCENT PATIENTS (AGED 12-17 YEARS OLD)

BACKGROUND: Published guidance from the FDA, EMA, and ISPOR Task Force acknowledge that developing COA measures for use in adolescent populations (aged 12-17 years old) presents unique challenges beyond those found in other age groups. Recognized as a very diverse age group in terms of academic ability, specific aspects of COA measure development should be considered to ensure outcome measures are appropriate across the age range, such as...