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Patient-reported outcome (PRO) translations have long required linguistic validation before use in clinical trials, so with the rise of digital instruments in decentralized clinical trials, what additional considerations are there for electronic PRO (ePRO) translations? PROs are a key clinical outcome measure (COA) used to understand how a patient feels about a treatment, and are essential for patient-centricity in clinical trials. Translation of these measures must not only be accurate but also provide cultural equivalency of the outcome metric to ensure that trial results are comparable across global study sites. In addition to the linguistic validation needed for traditional PRO translation, ePRO translation may also involve cultural adaptation of digital elements, from website translation and GUI review to software localization.

Traditional PRO Translations and Linguistic Validation

While regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) recommend validation of clinical trial instruments, it has fallen on industry to build best practices for PRO translation such as those developed by ISPOR in 2005. The standard for PRO translation is a multi-step linguistic validation process, including forward and back translation, harmonization, and cognitive debriefing to ensure that the measures are understandable for non-clinicians, have consistent terminology across languages, and are culturally adapted. However, these best practices were created prior to the COVID-19 pandemic and growth of decentralized clinical trials that rely on digital data collection, such as ePRO.

Decentralized Clinical Trials Prioritize Patient-Centricity and Trial Endpoints

Decentralized clinical trials (DCTs), clinical trials that are partially or fully conducted remotely, have grown in popularity with patients, clinicians, and sponsors for several reasons. A study from Tufts Center for the Study of Drug Development showed that DCTs not only reach endpoints quicker, but they have a five to 14 times higher financial ROI for sponsors. For clinicians, elevating electronic data collection directly from patients ensures more accurate real-world data across multiple study sites, and may even improve patient outcomes. Additionally, DCTs enable patients who would not otherwise participate in clinical trials – particularly diverse patients with additional language needs – to participate. With these advances in clinical research, global DCTs aren’t going anywhere, and neither are the translation needs for multilingual ePROs.

Web- and App-Based ePRO Translations

ePROs come in many formats, from website-based questionnaires and patient diaries (or ePatient Diaries) to mobile medical apps that record patient testimonials at regular intervals. In addition to linguistic validation of the translated metrics, these websites and apps must also undergo localization to be appropriate for different study sites. This may entail terminology management for the entire digital system in multiple languages, software graphical user interface (GUI) localization, and cosmetic and functional testing of the instrument. And as the evolution of healthcare and clinical research into the digital space grows, such as integration of clinical trial software into electronic health records (EHRs), accurate and effective ePRO translations will be even more crucial for recording patient voices across languages.

CSOFT Health Sciences, Leaders in Medical Translations

CSOFT Health Sciences’ global team of linguists has over 7 years of in-country experience to best perform our 11-step linguistic validation process that combines forward and back translation, reconciliation and harmonization, cognitive debriefing, proofreading, and more. Along with subject matter experts in website and GUI design, software localization, and a full range of therapeutic areas, we translate clinical outcome assessments from PROs and ePROs to clinician-reported outcomes (ClinRO), performance-reported outcomes (PerfRO), and observer-reported outcomes (ObsRO) in 250+ languages. Visit to learn more about our ePRO translations.