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.