Why Linguistic Validation is Important for Clinical Research Translations

welocalize August 22, 2020

Whether it is marketing a new medical device or putting a new drug on the market, the life sciences sector requires highly technical approaches when it comes to translating content for pharmaceutical, biotechnology, medical device, healthcare, and clinical research stakeholders.

Clinical outcome assessments (COAs), especially patient-reported outcomes (PROs), play an integral role in whether a device or medication makes it to the market. They provide valuable information that can impact the validity of a clinical trial. For this reason, COAs must undergo one of the most rigorous translation processes called linguistic validation.

Welocalize Life Sciences shares why additional quality assurance steps are necessary for clinical research translation projects and how the process is conducted.

What It Is

Linguistic validation refers to a process where the translated text is actively tested with clinician review and/or cognitive debriefing in the target population. The overall objective is to ensure that the translated documents are conceptually appropriate and linguistically accurate.

Why Linguistic Validation is Important

COAs are a measure that describe or reflect how a patient feels, functions, or survives. They are often used to measure if a given treatment is effective. There could be serious implications such as an entire clinical trial being invalidated if proper data collection was not done due to ambiguous or incorrect translation.

The linguistic validation process is designed to ensure the translation conveys the same meaning as the original source content or is properly adapted to the target population. This involves a series of quality assurance checks to make sure the translation is as linguistically and culturally accurate as possible.

COAs are often used to measure if a given treatment is effective. There could be serious implications such as an entire clinical trial being invalidated if proper data collection was not done due to ambiguous or incorrect… Click To Tweet

The Process

Linguistic validation encompasses many translation steps and a clinician review and/or cognitive debriefing step. All linguists involved are native speakers of the target language and experts in the field of study. Here are the complete steps:

Step 1: Translatability Assessment

Before starting any linguistic validation process, a translatability assessment is performed to avoid ambiguities in the source and to foresee issues that may occur during the localization of source text into another language. Based on the findings, a discussion with the client may be initiated to obtain suitable alternatives and options for ambiguous wording and phrases if needed.

Step 2: Forward translation

Two translators will translate independently the source content into the target language, producing two translated versions.

Step 3: Reconciliation

An independent linguist analyses the two forward translations against the source and reconciles them into a single forward translation.

Step 4: Editing

The linguist edits the reconciled version and makes sure it mirrors the source and is error‑free.

Step 5: Back translation

The reconciled translation is then back translated into the original source language.

Step 6: Equivalency stage

At this stage, the back translation is compared to the original source to identify any discrepancies. Based on the findings, the forward translation team and the back translation team will ensure to correct any mistranslations, omissions and additions that impact the originally intended meaning of the source to produce the finalized version for linguistic validation.

Step 7: Linguistic Validation via Clinician’s Review and/or Cognitive Debriefing

  • Clinician review: the finalized translation from step 6 will be reviewed by an in‑country clinician who is an expert of the field of the study. The clinician will detail proposed changes and/or clarifications for consideration in a report.
  • Cognitive debriefing: focus group is the most common way of performing cognitive debriefing. To perform cognitive debriefing with focus group, a small group of individuals from the target country is asked to evaluate the translated document based on their own education level or backgrounds. The cognitive debriefing can also be performed in a one to one setting if needed.

Step 8: Final Translation Revision

The forward translation team and back translation team will revise the translation based on findings identified in the clinician review report and/or cognitive debriefing report. The Quality Assurance team will finalize the translation and make sure the layout of translation mirrors the source.

There are strict regulations around the translation of the clinical outcome assessments. Welocalize Life Sciences Linguistic Validation process meets the requirements of the regulations and follow the ISPOR guidelines. In addition, we have also established workflows based on PROMIS/FACIT methodology, a more complex process to validate scales.

Ensure your clinical outcome assessments are accurately translated and properly localized. Contact us for more information.