Managing Cultural Variability in PRO Measurement in Global Clinical Research Part 3: Quantitative Approaches for Clinical Outcome Assessment in a Cross-cultural Context

Too frequently, evidence generation on endpoints playing a key role in the value demonstration story fails, not because the product is not doing well, but just because the measure missed the point. The globalization of clinical research has strong implications for outcomes measurement since psychomodulated measures such as Patient-Reported Outcomes (PROs) or Clinician-Reported Outcomes (ClinROs) are commonly included in international clinical studies. Due to the sensitivity of such scales to culture, their cross-cultural equivalence can be as important as is centralized laboratory testing for the successful development of a product.

This Mapi webinar program will encompass the three key steps that maximize cross-cultural equivalence of scales assessing patient benefit and safety in international research.

1) Laying stable foundations for high-performing, powerful, sensitive measures through simultaneous development of scales in multiple languages;

2) Maximizing the cross-cultural equivalence of all the language versions using rigorous linguistic validation;

3) Applying data analysis methods focusing on cross-cultural validity to maximize power and avoid misleading conclusions Each step will be illustrated with real examples and current issues will be submitted to participants to substantiate the challenges that are associated with the utilization of PRO measures in a global context.

Part 3: Quantitative approaches for clinical outcome assessment in a cross-cultural context

This third webinar of the series will focus on the data analysis questions related to clinical outcome assessment in multinational clinical trials. The demonstration of treatment benefit might be impacted in multinational trials when it is assessed for clinical outcomes that are likely to be sensitive to culture, which is the case of most patient-centred outcomes.

During this presentation, you will learn about:

• The risk for the evaluation of treatment benefit of assessing clinical outcomes in a cross-cultural setting
• The methods allowing the cultural variability of the assessment to be assessed using trial data
• The existing solutions to control the risk pertaining to clinical variability in a multinational clinical trial, in terms of study and statistical analysis design

Speaker

Antoine Regnault, PhD, MSc, MA , Research Director, Mapi HEOR & Strategic Market Access - France

Mapi HEOR & Strategic Market Access – France Antoine leads the Statistics & Psychometrics team of Mapi HEOR & Strategic Market Access. Antoine has more than 10 years of experience in patient-centered outcome data analysis. His current role involves consulting on projects requiring statistical expertise, particularly on questions concerning cross-cultural validity of scales. Antoine has advanced skills in psychometrics and sophisticated statistical analyses, such as Structural Equation Modeling and Differential Item Functioning detection techniques. He has also worked on statistical methods for the development of patient scales for clinical practice, and has thus acquired specialist skills applicable in a large number of fields, both in clinical trials and clinical practice. Antoine is a co-author of several papers on patient-centered outcome data analysis and has presented his work at a number of international scientific conferences. He is an active member of the Special Interest Group “Translation and Cultural Adaptation” of the International Society of Quality of Life (ISOQOL). He is a research fellow of an academic team of the University of Nantes (“Biostatistics, Pharmacoepidemiology and subjective measures in health sciences”). Antoine has PhD in Applied Statistics from the University Claude Bernard Lyon 1; the topic of his dissertation was the use of quantitative methods for assessing the cross-cultural validity of PRO instruments. He also has an MSc in Biostatistics from the University Victor Segalen Bordeaux 2, and an MA in Health Economics from the University Lyon 1.

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