| Jessica Eker at TransPerfect Translations Ltd looks at the key steps for success in linguistic validation
To anyone in clinical research, patient-reported outcomes (PROs) are familiar and critical tools for gathering valuable insight into symptoms, side effects and safety, with regard to drugs under study. Compiling this information is a necessary and important step in getting a particular treatment from the lab to hospitals and pharmacies. However, as clinical trials become increasingly global and reach into more diverse cultures, a number of complicating factors can make this stage among the most challenging in the process of obtaining regulatory approval.
During the PRO stage, which typically occurs in the late phases of clinical trials, written or oral surveys are conducted so that patients can provide information about their medical history and their experience of a given treatment. Naturally, pharmaceutical companies face the inherent hurdles of evaluating patients’ qualitative responses and transforming them into quantitatively valid results. The expansion of global trials has further complicated these hurdles and created additional barriers requiring a level of expertise all its own. Conveying technical information to large groups of people from different cultural and educational backgrounds, as well as integrating those responses from Japanese, English, German and Spanish into a single language, creates an entire additional process when assessing PROs.
Linguistic validation is a methodology that allows researchers to better manage the complexities of international studies by preparing a cognitively equivalent instrument – a document that, when presented in aggregate, will approximate the same meaning across diverse linguistic and cultural groups.
In the process of linguistic validation, linguists perform several rounds of translation and then submit the document to native speakers who carry out the cognitive debriefing, or pilot testing. Though the methodology for the linguistic validation process has become better defined over the past decade, workflows still vary between organisations that offer the service. Non-regulated parts of the process – such as instrument delivery to the various sites and verbal, unscripted instructions given to patients by the in-country investigators – can further compromise the results if not clearly established in advance. Therefore, it’s of critical importance to be completely familiar with every aspect of linguistic validation and to take a holistic approach in identifying and addressing contingencies that may arise. Additionally, companies can count on better outcomes, and complete the clinical trial process faster and with a higher degree of accuracy, when they view linguistic validation as one part of a whole clinical trial process. |
