Managing Cultural Variability in PRO Measurement in Global Clinical Research Part 2: Maximizing Cross-cultural Equivalence of PRO Measures: The Linguistic Validation Methodology

Are you sure all the patients answered the same question in your multi-national pivotal trial?

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 2: Maximizing Cross-cultural Equivalence of PRO Measures: The Linguistic Validation Methodology

When Clinical Outcomes Assessments (COA) such as PRO instruments are used in international clinical trials, it is crucial to ensure that equivalence is addressed during the development of translations. This will allow data to be safely compared across countries and languages.

The process aimed at the production of consistent and harmonized language versions is referred to as Linguistic Validation.

In this webinar, the speakers will focus on:

1) Context of use of COA translations and recommendations in the field including FDA, EMA, and ethics committees.

2) What is linguistic validation and why it is important?

2.1 Linguistic validation vs. translation

2.2 Does the type of COA (e.g. Clinician-Reported Outcomes) have an impact on the linguistic validation process?

2.3 Real examples of challenges encountered during linguistic validation

3) How to assess the reliability of the linguistic validation process and the quality of a COA translation.

Participants will learn how to be prepared when using COAs and translations in international clinical trials and anticipate operational considerations crucial for the studies.

Speakers

Axelle Nadjar, Key Account Director – Linguistic Validation, Mapi

Axelle has more than 14 years of experience with Mapi. Since joining the company in 1999 she has acquired a deep knowledge of the linguistic validation project management, and developed an expertise with a significant number of instruments in various therapeutic areas. In 2003 she joined the Sales team as a Key Account Director, while still supervising challenging multi-instrument projects covering more than 50 languages.

In this capacity Axelle adapts questionnaires for use in other countries, and provides developers with linguistic validation input into the development of instruments in other languages. She has been deeply involved in assisting Mapi’s clients in the education of their teams on the purposes and processes of linguistic validation. She has also moderated workshops on the subjects at international conferences including ISOQOL.

Axelle holds two post-graduate degrees; one in English Linguistics and Civilization and a second in Biomedical Translation.

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Caroline Anfray, Business Development Director – Linguistic Validation, Mapi

Caroline has more than 20 years of experience at Mapi. Since joining the company in 1993 she has developed an in-depth expertise in the PRO field on many levels:

• Authorship and intellectual property specific to these types of instruments
• Unique business model for the international distribution of PROs and their translations
• PRO literature searches
• “Personalized relationship” with more than 100 developers
• PRO & ClinRO translations

Caroline’s wealth of knowledge in this area has enabled her to naturally transition in 2010 from her previous position as the head of the PRO Information Unit to her current position as a Business Development Director for the Linguistic Validation Business Unit. All while supervising the strong Mapi relationships with PRO developers in academia.

In this capacity, she has been deeply involved in assisting the pharmaceutical companies understanding all of the specifics of this particular field, by educating their teams, and developing the solutions adapted for their PRO needs. She has organized numerous personalized educational programs for them, published key reflection papers in the domain and moderated workshops in renowned international conferences including ISPOR and ISOQOL.

Caroline holds two degrees. One in communication from Ecole Française des Attachés de Presse, and a second in Spanish Language and Civilization from the University of Caen where she graduated with honors.

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