戻る Agenda
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
University of Washington, United States
Professor, Health Services, School of Public Health
Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques
Ashley F. Slagle, PHD, MS
Aspen Consulting, LLC, United States
Principal, Scientific and Regulatory Consulting
Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques
James P. Stansbury, PHD, MPH
FDA, United States
Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER