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With regulatory documentation presenting an enormous range of requisite communications and regulatory filings, why is linguistic validation for patient questionnaires such an important area of focus for international clinical trials? As an increasing number of linguistically and culturally diverse patients are represented in clinical trials, retaining high rates of patient engagement and accurate data is a priority for all stakeholders. Yet, a persistent obstacle in the current clinical trial space is connecting with patients in different languages and it necessitates high-quality translations for patient-facing documents. To navigate this challenge, linguistic validation for patient questionnaires is a crucial process for international clinical trials to ensure that patient-focused documents remain clinically accurate and enable patients from all backgrounds and levels of health literacy report valuable data and health metrics.

Linguistic Validation for Patient Questionnaires, Step-by-Step

For the purpose of promoting patient engagement and upholding a patient-centric data reporting model, linguistic validation requires multiple steps and a combination of subject matter experts, linguists, and translators to ensure accuracy and consistency in clinical outcome assessments (COAs) documents, including eCOA questionnaires, ClinRO questionnaires, PRO questionnaires, ObsRO questionnaires, PerfRO questionnaires, and patient diaries.

The process of linguistic validation Includes the following steps:

  • Dual Forward Translation
  • Harmonization Process
  • Back Translation
  • Clinical Review
  • Cognitive Debriefing

Following the initial dual forward translation, a separate linguist combines both translations into a single, more accurate translation during what is referred to as the harmonization process. Next, the document is back-translated from the target language into the source language to eliminate any remaining linguistic or grammatical inaccuracies. During the clinical review step, a medical professional reviews the translated document to ensure it is clinically accurate and acceptable for a clinical trial. Lastly, the cognitive debriefing process includes an independent review with individuals who natively speak the target language to ensure the finalized questionnaire is culturally appropriate and comprehensible.

How Linguistic Validation for Patient Questionnaires Impacts Clinical Trails

As more and more clinical trials aim to represent a larger percentage of culturally diverse populations, language becomes an integral part of patient recruitment and patient engagement and requires clinical trial stakeholders to ensure that COA questionnaires can meet the language needs of all trial participants. Additionally, regulatory agencies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) issue guidance and recommendations for COA documents that are used in international clinical trials and intended to capture patient data. While one of the main objectives of linguistic validation is to promote an increased representation of diverse study subjects and encourage more engagement throughout the clinical process, this process also supports data equivalency and directly benefits the sponsor of the study. Rather than losing valuable data due to poorly translated questionnaires, linguistic validation ensures consistent and accurate data can be captured in a patient-centered lens. With much change occurring in the global clinical trials market, the fastest growth is emerging in linguistically diverse countries like India and China, which for overseas sponsors, means that high-volume translation needs are essential to meet this demand.

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