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The Increasing Importance of Linguistic Validation in the Healthcare Product Lifecycle

Rigorous and technical translation processes guide the development of content for a variety of products across the healthcare ecosystem. Patients, caregivers, clinicians, study site leaders and other key stakeholders rely on accurate information for research or care delivery in the pharmaceutical, biotechnology and medical device markets. Marketing finished endpoints, such as new drugs, therapies, treatment programs and devices, also requires precise language that is truthful, easy to understand and compliant with industry regulations and standards. As clinical trials become more globalized, spanning several phases and worldwide patient populations, and as advances in science and technology fuel more opportunities for new healthcare solutions, expert services like translation and linguistic validation serve an increasingly vital role in the healthcare product lifecycle.
Review the value of linguistic validation and dive deeper into how translations function with an experienced service provider in clinical research or care delivery.
What Is Linguistic Validation?
Linguistic validation is the process of evaluating the dependability, conceptual equivalence, and accuracy of translations. When translations are produced, linguistic validation takes that content and tests it against the population it is targeting through cognitive debriefing or clinician examination.
Healthcare measures that help researchers gain insight into patient experiences are crucial elements of developing new products like drugs and medical devices—and they require thorough linguistic validation. Patient-reported outcomes (PROs), a specific type of clinical outcome assessment (COA), are measures that offer valuable information reported directly by patients or study subjects, rather than by clinicians, caregivers or outside observers. PRO data on patients’ quality of life, functional health and well-being can be used at any stage of the healthcare product lifecycle, including product development, regulatory approval, payer communication, product marketing and population health.
Because PRO measures typically come in the form of questionnaires, surveys and interviews directed at patients, the content they collect is highly subjective. In order to obtain the best results for researchers, patient-reported outcome measures must be designed to leave no room for misinterpretation by participants and to perform statistically the same way across all available languages. This is where linguistic validation comes in.
Materials Requiring Linguistic Validation

  • Manuals
  • Protocols
  • Case Report Forms
  • Consent Forms
  • Interview Scripts
  • Metatext

Why Is Linguistic Validation Important?
The need to conduct clinical trials among international patient populations continues to grow, allowing researchers to gather invaluable datasets and giving participants the opportunity to receive care for lived diseases or conditions. As data from patient populations increases, the translation of scientific data for these trials goes beyond the capabilities of basic translation tools. Simply swapping one word for another doesn’t suffice in healthcare. Translations should be handled by experienced professionals who are trained to maintain cultural and linguistic equivalency across languages so that content is as accurate and unambiguous as possible for native speakers and readers.
To pursue global initiatives, sponsors and sites must design studies that take into consideration various target languages, literacy levels, demographics, backgrounds and cultures. Not only will this create easier, more straightforward experiences for participants, but it will also proactively address potential roadblocks with data collection and analysis.
Poorly translated documents and materials for clinical outcome assessments may influence survey responses and lead to inconsistent, inconclusive data pools or invalidated trials. COA measures are built to gather patient perspectives that ultimately aid in the evaluation of disease progression, health impact, treatment efficacy, quality of care and countless other aspects of the patient journey. Successfully achieving these goals is only possible when researchers can deploy instruments and programs that contain trusted, validated content.
Core Functions of Linguistic Validation

  • Ensure content is reliable, valid and conceptually consistent
  • Hold health measures to higher quality standards
  • Support high-quality data collection and data analysis
  • Allow clinical trials to reach international patients
  • Align content with target population’s culture and literacy
  • Prevent mistranslation and invalidated clinical trials

How Is Linguistic Validation Achieved?
In 2009, the FDA began to require evidence from clinical trial sponsors of content validity and version consistency for their patient-reported outcomes. Whether the PRO measure was developed in parallel for multiple language and cultures or translated from one original tool, the FDA intends to review the processes sponsors used to produce accurately translated and culturally adapted PRO instruments.1 Although all types of COA measures should be held to these standards, the FDA’s recommendation encourages healthcare professionals across the industry to take linguistic validation patient-reported outcomes projects seriously.
The methods used to achieve linguistic validation may look different depending on the sponsor or provider offering language services. Many tools utilize separate translations of the same content merged into one version that is then translated back into the original language and compared to the source material. This does not always translate with the high accuracy necessary for scientists, clinicians and researchers.
Expert translation and linguistic validation services are comprised of several detailed steps that are carried out by skilled native speakers, clinicians and scientists. During translations, emphasis is placed on maintaining an appropriate reading level and conceptual equivalence among languages so the same meaning and accessibility is carried across translated content.
Before beginning these steps, a translatability assessment is performed to help determine the overall suitability of proposed translations as well as remove any ambiguities in the source material and detect foreseeable issues that may occur should translations be completed. QualityMetric conducts translatability assessments by designating difficulty ratings shared in a final report, allowing healthcare organizations leading clinical trials to easily identify and proactively address problematic areas in their original content.

The best translators to involve in linguistic validation should hold linguistic expertise but also deep knowledge of country-specific guidelines relevant to the project and an understanding of end-to-end drug development, medical device development and other key healthcare processes. Linguistic validation procedures must closely follow FDA and ISPOR recommended methodologies, applicable regulatory authority requirements and current clinical research best practices.
QualityMetric’s extended network of U.S.-based linguists and in-country translators provide cross-cultural adaptations and linguistically validated translations of all varieties of clinical and scientific content for more than 200 translations across global research locations. Achieve the linguistic validation outcome your team desires with help from the experts at QualityMetric.
Learn more about our translation and linguistic validation services designed to help patients easily and accurately understand content in multinational studies, projects and programs.

  1. U.S. Department of Health and Human Services, Food and Drug Administration. Patient-reported outcome measures: Use in medical product development to support labeling claims. U.S. Food and Drug Administration. 2009.