Stacie Hudgens, MSc
Clinical Outcomes Solutions
Stacie Hudgens is chief executive officer and strategic lead at Clinical Outcomes Solutions with over 20 years of pharmaceutical industry, academic and consulting experience, specializing in quantitative science. She is currently the co-chair of the Psychometric Special Interest Group at ISOQOL.
She has over 20 years of research experience, specializing in research design and statistical and psychometric analysis with extensive U.S. and European Regulatory submissions and presentations including participation on the U. S. Food and Drug Administration’s Study Endpoints and Label Development group’s Mixed Methods Panel. She brings 13 years of experience in clinical trials and health and economic outcomes research and four years of experience in educational measurement and has developed webinars and symposiums on mixed methods including small sample size psychometric and statistical methodologies.
Her experience in health economics and outcomes research includes psychometrics, clinical and observational research design, item development and validation, patient-reported outcomes (PROs) in clinical trials, economic modeling, secondary data analysis, and longitudinal and missing data analysis. In addition, she specializes in development of health economic and outcomes studies for regulatory and commercial consideration. She was awarded an early career investigator’s award by ISOQOL for her psychometric methodologies in cross-cultural validation of the FACT-BRM in chronic myeloid leukemia during her tenure as a senior statistician at Evanston Northwestern Healthcare.
Hudgens has worked and published extensively in multiple disease states with extensive expertise in oncology and diabetes, and has worked cross-functionally with regulatory, biostatistics and marketing groups to inform and support PRO measurement strategies in product development. Prior to her position at Adelphi Values, Stacie held dual roles as the PRO, statistical and psychometric expert as well as leading the internal studies team of a large pharmaceutical company in the area of global health economics and outcomes research. Previously, she held an adjunct faculty position at the Chicago School of Professional Psychology where she taught research methods, introduction and advanced statistics.
She developed multiple workshops for surgical residents at Evanston Northwestern Healthcare in clinical research design and statistics. She has also worked extensively with medical board certification agencies teaching item response theory as well as instrument and item design.