Translation and linguistic validation is a fundamental part of the patient reported outcome (PRO) instrument development process. When properly done, this process ensures that PRO data pooled from international clinical trials has scientific validity, and hence credibility with regulators and the marketplace. (Regulators, including the FDA and EMA, increasingly require that fully compliant Translation and Linguistic Validation processes underlie evidence used to support regulatory submissions and labeling claims.)
Because there are so many questions about the what, how, when of linguistic validation, we are pleased to have industry expert Mark Gibson present Linguistic Validation Practices for PRO and QoL Measurement Tools.
Mark will explain how the linguistic validation process ensures that translated versions of a source text contain conceptual, semantic and pragmatic equivalents to the original source text. He gives examples of how linguistic validation can also assure that the translated content is culturally appropriate, relevant and meaningful for the document to be used in the target countries.
Increasingly, large-scale clinical trial programs are conducted in non-English countries, and the need to translate and adapt clinical trial documentation for use in other than the source language continues to rise in demand.
To get a sense of Mark's expertise, take a look at his paper A critique of the linguistic validation process for Patient-Reported Outcomes and Quality of Life instruments [PDF] - and then listen to him present. Highly recommended!
For more on PROs and linguistic validation, take a look at the following:
- Linguistic validation of PROs demystified
- FDA final PRO guidance will increase demand for linguistic validation
- Translation & Linguistic Validation of PRO Measures
ForeignExchange Translations provides specialized medical translation support for all stages of drug and device clinical research.