Linguistic validation is a process of translating, reviewing and validating the accuracy, reliability, and conceptual equivalency for patient reported clinical outcome assessments (COAs). CSOFT Health Sciences manages the entire life cycle of an extended process of translation and quality assurance practices that are aimed at verifying technical documents and instruments. Linguistic validation for licensed COAs, however, can be more complex and time consuming when conducting time sensitive global clinical trials.
Background on COAs in Clinical Trials
Outcome Assessments (COAs) are critical to any clinical trial that records a patient’s quality of life by ensuring that their voice is both heard and considered throughout the research. While a patient’s physical condition is measured with tools such as thermometers and imaging devices, COAs assess their quality of life and subjective healthcare experience to shed light on all the potential effects of the product being researched.
COAs are subdivided into four categories depending on how they are completed: Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs), and Performance Outcomes (PerfOs). All COAs are created by a developer or developers who either control their use or allow public usage. Because there are no overarching rules or regulations that dictate how developers should control the use of their COAs, identifying ownership can be tricky to say the least. Considering that additional copyright claims can exist for translated versions of COAs, the process of conducting linguistic validation for global clinical trials can become exponentially more complex and time consuming.
Click on the following to learn more about PRO Translations or the Importance of Localization in Global Clinical Trials from Protocol to Patient
What Comes First? The Relationship Between COAs and Linguistic Validation
Linguistic validation for global clinical trials is the process of ensuring that COAs are culturally appropriate, accurate, and conceptually equivalent to the original, resulting in data that is reliable and valid data across different languages and regions. The linguistic validation process is an industry best-practice. As an example, if a trial involves patients in Chile, a linguistically validated Spanish version specific to Chile should be employed rather than a generic Latin American Spanish version. The “one version per language per country” model is crucial for consistent and comparable data across the world. Consider the case of a PRO evaluating levels of tiredness: the Spanish translation of the term “fatigue” may vary among the 20+ Latin American countries. Therefore, using a country-, and sometimes even a region-specific, version minimizes potential confusion and inaccurate data.
Check out the following to read more on The Importance of Linguistic Validation for Clinical Trials
Why the Linguistic Validation for Licensed COAs Matters
Using the correct COA version for the countries studied in a clinical trial isn’t just about convenience—it has a direct effect on the quality of data collected, regulatory compliance, and the trial’s timeline. If a linguistically validated version does not exist, sponsors will need to create one, which requires a strenuous process of forward and back translations, cognitive debriefing, and more. The new version then becomes the copyright holder’s intellectual property, further complicating the logistics of conducting global trials. It is vital that clinical trial sponsors acquire the license for the use of the correct version from the copyright holder. Copyright holders can be the original developer, the organization that employed the developer at the time of creation, the journal in which it was initially published, or even heirs of the intellectual property. Given these time and licensing intricacies, sponsors should plan for linguistic validation as early as possible when designing a trial. Delays in obtaining licenses or linguistically validating COAs are common and often lead to postponed trials and increased costs.
Real Life Implications of Linguistic Validations for Licensed COAs
A 2021 Trials article titled, “Systematic review of the use of translated patient-reported outcome measures in cancer trials,” underscores the importance of using properly localized Clinical Outcome Assessments (COAs), despite the challenges and costs associated with licensing. The study revealed that “(a)vailability of translated and culturally validated PROMs (patient response outcome measures) was a concern raised in some of the interviews” and that “(t)he rationale is that to meaningfully accommodate linguistically and culturally diverse participants, translated and culturally validated PROMs should be used to facilitate data collection (Slade et al., 2021).” With the rise of global clinical trails, it is becoming increasingly clear that correctly translated and validated documents should be a priority to ensure the standard of care remains consistent for all patients regardless of their language background.
This research stressed that for COAs, “It is important these effects are captured for all participants, via their access to linguistically translated and culturally validated PROMs, preventing additional issues and potentially improving survival outcomes.” Despite this, they pointed out a worrying trend: “The lack of transparency around the use of culturally and linguistically validated PROMs in the multi-national trials demonstrates a concerning pattern of non-inclusion of international trial participants… (Slade et al., 2021).” Considering this information and the fact that international trials are increasing each year, it is more crucial than ever to ensure that every has considered how it will make all COAs accessible all patients from the start. From this revelation, it is clear that the barrier of certified linguistic validated remains even when prioritizing inclusion for all languages.
The Rise of eCOAs and Digital Adaptation
With digital technologies reshaping clinical trials, the industry is seeing a surge in electronic COAs (eCOAs). According to a 2024 study on “Flexible approaches to eCOA administration in clinical trials,” researchers noted, “the respondents reported feeling positive when learning that eCOA would be used in a trial… Further, when asked their impression of participants’ attitudes toward eCOA, most reported a positive response… These results suggest that sites have an appreciation for the importance of eCOA data collection as well as confidence in their ability to learn and use eCOA” (Haenel et al., 2023). With digital literacy becoming an everyday skill for most people, it is abundantly clear that eCOAs are here to stay and represent the future of patient response data. With that said, adapting many COA tools for electronic use presents a slate of new challenges, such as ensuring that questions remain readable and interactive on all digital platforms, like tablets and smartphones. A poorly adapted eCOA can lead to reduced patient engagement, compromising the integrity and efficacy of the data.
Check out the following link to learn more about CSOFT’s eCOA Translation Services or Linguistic Validation for eCOA Translations
Partnering with CSOFT Health Sciences for Linguistic Validation
CSOFT Health Sciences’ prioritizes the accuracy and cultural relevance of localized COAs, which is crucial for maintaining the integrity of patient data collected in clinical trials. To achieve this, we employ the rigorous, industry-standard 11-step Linguistic Validation Process for COAs:
- Preparation: Initial research; Patient recruitment; Scope definition; Licensing; Translatability assessment
- Forward Translation: Development of at least 2 independent forward translations
- Reconciliation: Reconciliation of forward translations into a single one
- Back Translation: Back Translation of the previous translation into the source language
- Back Translation review: Review of the back translation against the second language
- Harmonization: Harmonization of translations across all languages to review against the source again
- Clinician & Client Review: Subject matter experts review for accuracy and appropriate terminology
- Cognitive Debriefing: Cognitive debriefing of the new translation, usually with patients drawn from the target population
- Review of Cognitive Debriefing: Cognitive debriefing results are reviewed, and the translation is updated
- Proofreading: The finalized translation is proofread (e.g. types, layout issues)
- Final Report: Report written on the translation’s document
Each step of our linguistic validation service is designed and tested to maintain the conceptual equivalence of the original text while adapting it to the linguistic and cultural context of the target population. For a more intuitive understanding of our linguistic validation process, check out our YouTube video where we walk through each step of the methodology in greater detail. By following this comprehensive approach, CSOFT helps our clients navigate the complexities of multilingual, worldwide trials to produce reliable, consistent, and high-quality data for global submissions. With prior knowledge of the potential barrier of linguistic validation for licensed COAs, clinical trial conductors can arrange for the correct translation and language services to ensure that the health of patients worldwide and to ensure the trial remains on time
References
- Slade, A. L., Retzer, A., Ahmed, K., Kyte, D., Keeley, T., Armes, J., Brown, J. M., Calman, L., Gavin, A., Glaser, A. W., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Turner, G., & Calvert, M. J. (2021). Systematic review of the use of translated patient-reported outcome measures in cancer trials.Trials,22(1), 306. https://doi.org/10.1186/s13063-021-05255-z
- Haenel, E., Elash, C. A., Garner, K., Turner, M., Kern, S., & Electronic Clinical Outcome Assessment (eCOA) Consortium and the Patient-Reported Outcome (PRO) Consortium (2023). Flexible approaches to eCOA administration in clinical trials: The site perspective.Contemporary clinical trials communications,37, 101241. https://doi.org/10.1016/j.conctc.2023.101241