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.
A key methodology for the evaluation of therapies is the randomized controlled trial. These clinical trials traditionally relied on relatively objective clinical outcome measures, such as cure, biological response to treatment, or survival.
In recent years, however, patients and investigators alike have argued that subjective indicators should be considered as well. These indicators are regarded as indicators of quality of life. Many questionnaires, or instruments, have been developed for quality of life assessment, and the demand to translate them has increased year after year.
The translation of these Quality of Life (Qol) or Patient Reported Outcomes (PROs) is referred to as Linguistic Validation. The name implies both linguistic and conceptual equivalence across languages and cultures, and is achieved through the most intricate methodology in the translation industry.
The Linguistic Validation process includes two forward translations performed by native speakers of the target languages who are working independently. It is then followed by a reconciliation of the forward translations into a first draft translation by another native speaker of the target language.
This linguist, known as the Reconciler, plays a key role in the Linguistic Validation methodology, because it is the Reconciler who updates the draft translation several times during the process and who ultimately has the final say on whether or not the translation may be considered final and, thus, validated.
After Reconciliation, the reconciled version is back translated into the source language by a native speaker of the source language, usually English. The Back Translation (BT) step is followed by a comparison of the BT and the source, called Comparative Review, performed by a native speaker of the source language who has undergone our Comparative Review training.
The draft translation is then updated by the Reconciler and sent for review to a clinician in the target locale and in the specialization targeted by the instrument. The draft translation is updated again, if necessary, formatted, and sent to a healthcare professional who interviews five patients who have the disease or condition targeted by the instrument.
This interview process is called Cognitive Debriefing. Patients are asked if they understand the translations, if the language is offensive or irrelevant to them, and if they would change any of the wording. Patient feedback is evaluated after the Cognitive Debriefing step, and, once again, the draft translation is revised by the Reconciler, if needed. Finally, the validated translation is formatted and final review before delivery to the customer.
For more on linguistic validation for Qol and PROs, 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.