Managing Cultural Variability in PRO Measurement in Global Clinical Research Part 1: Cross-cultural Qualitative Research for Simultaneous Scale Development

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 webinar 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.

The speakers will focus on the conduct of international qualitative research during the fundamental step of concept elicitation and item generation. During this presentation, you will learn about:

• How to prepare the ground for successful simultaneous development
• Key steps in performing simultaneous development
• Practical issues and how to handle them

Speakers

Benoit Arnould, PhD, Senior Director, Mapi

Benoit leads the Mapi consultancy team specialized in Outcomes Research. Benoit has been conducting studies to develop, validate and interpret Patient-Reported Outcome (PRO) and Clinician-Reported Outcomes (ClinRO) measures for 15 years. He has experience in a wide variety of conditions in all major disease areas and age-groups. Developing new scales simultaneously in several languages, with international advisory board of clinicians, is one of his preferred professional activities.

Previously a statistician in a veterinary epidemiological research unit and in the Pharmaceutical industry, Benoit has sound knowledge of clinical and epidemiological trial design, data analysis and interpretation. He also has extensive practical experience of a number of different healthcare systems, having worked for several years in various countries in Africa and Asia. Benoit is a Health Economics graduate with a specialty in statistics, and completed, under the supervision of Professor Gerard Duru, his PhD on PROs for clinical decision making, a subject on which he publishes regularly.

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Nicola Germain, MA, Senior Research Associate, Mapi

Nicola has over 7 years’ experience in the PRO team at Mapi and has worked extensively on questionnaire development in several languages simultaneously. She is also closely involved in all steps of questionnaire development, including the development of conceptual models, the preparation and conduct of exploratory and confirmatory interviews and their analysis. She holds an undergraduate degree in French and German from Cambridge University, UK, and a postgraduate research degree from the Ecole Normale Supérieure in Lyon, France.

Nicola has previously worked in a number of fields, including international relations, unit trust investments and teaching. Nicola is a native English and German speaker, and she is also fluent in French.

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