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Conceptualization and Generation of a Draft Measure
Session Chair(s)
Elektra Papadopoulos, MD, MPH
Director, Patient Experience Data and Strategy, AbbVie, United States
Along with a clearly defined context of use, clear conceptualization provides the foundation for the process of instrument development. This is particularly important in clinical trials for regulatory purposes because the concept of interest becomes the labelling claim. Once there is clarity in conceptualization, the qualitative research process may begin.
Speaker(s)
Spoke 1: Conceptualization and Making the Case for Content Validity
Donald L Patrick, PhD, MPH
Professor, Health Services, School of Public Health, University of Washington, United States
Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques
Ashley F. Slagle, PhD, MS
Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC, United States
Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques
James P. Stansbury, PhD, MPH
Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER, FDA, United States
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