In the wake of the global coronavirus outbreak, and with around a third of the world’s population in varying forms of lockdown, the world waits with bated breath for the arrival of a vaccine for Covid-19.
A search of clinicaltrials.gov shows that there are hundreds of studies involving Covid-19 or coronavirus currently taking place across the globe. At the same time, the lockdown has led to a number of new studies being put on hold and enrollment being paused for others that are ongoing.
What role does the language industry play and where does linguistic validation, a complex and high-margin service, fit in?
A major part of bringing drugs to market is the clinical trial process, which must be completed before a drug can be approved for sale. In a significantly expedited process, experts are currently estimating that a coronavirus vaccine is at least a year away, and a number of pharmaceutical companies are poised to launch human clinical trials for their candidate vaccines.
The clinical trial process is a massive undertaking in and of itself; and, as it progresses, involves multiple trials among increasingly large groups of people. Phase 3 of the clinical trial process normally involves thousands of participants, most often across multiple countries.
Language Services in Clinical Trials
Clinical trials are highly regulated and generate a vast volume of documents, such as clinical trial results, including a subcategory of results known as patient-reported outcomes (PROs). Many of these documents require translation.
A specific subset of documents used during clinical trials is known as Clinical Outcome Assessments (COAs). COAs require special handling during translation via a complex workflow called linguistic validation.
In May 2019, Adelina Lear, Manager of Language Services at ICON plc, a contract research organization (CRO) that provides a range of services including clinical research, project management, regulatory review to pharmaceutical companies, spoke at SlatorCon London on the role of language services in the drug development lifecycle.
A large part of the translation volume that Lear’s team handles comes from patient-centered services such as clinical trials. “In a clinical study, you are trying to get patients enrolled across different sites and different countries. That’s where we see the most translation,” Lear said. According to Lear, linguistic validation is a key element of clinical outcome assessments (COAs) and quality of life materials.
Due to its complex nature, linguistic validation generates higher margins than standard translation workflows, but it by no means accounts for the majority of volumes within life sciences.
RWS, one of the world’s largest language service providers (LSPs) by revenue, generated around 18% of its sales from life science customers in 2019. Of the LSP’s GBP 65m in revenues from life sciences, linguistic validation accounted for 31% (or GBP 20m), with translation services contributing 69%.
Arguably the largest share of the market for life sciences language services is captured by US-based TransPerfect, however, whose early bet on this vertical more than a decade ago paid off.
Linguistic Validation Workflow
Linguistic validation is a best practice workflow. It is primarily applied to COAs, which are used in trials to assess the impact of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions.
COAs are used in patient reported outcomes (PROs), clinician reported outcomes (ClinROs), and observer reported outcomes (ObsROs) — and COAs must be translated when the persons involved speak a language other than the one in which the content was created.
The linguistic validation workflow is a response to the regulatory requirements relating to COAs. Requirements from regulatory organizations, such as the European Medicines Agency (EMA) and the Food and Drug Administration, are interpreted by professional industry associations, such as ISPOR and ISOQOL, which produce guidelines for best practice.
These guidelines form the basis on which LSPs have developed best practice linguistic validation workflows for translation of COAs.
Although there may be some variation in the way LSPs execute and refer to specific steps of the linguistic validation workflow, the ISPOR Principles prescribe 10 steps that should be included for linguistic validation.
The Principles set out what each step should include and who should be involved. There are also “critical components” of each stage and an accompanying “rationale,” as well as an outline of risks associated with not carrying out the correct steps.
Editor’s note: This article has been update to reflect details included in Eli Lilly’s update on March 23, 2020 that they plan to delay “most new study starts and pause enrollment in most ongoing studies” in light of the Covid-19 pandemic. Lilly said it is continuing ongoing clinical trials for patients who are already enrolled. Other pharmaceutical companies are likely to take a similar course.