Focus

How to ensure clinical trial translation quality

product strategy
Pia Windelov headshot

Pia Windelov

Pia Windelov is director of product strategy for Lionbridge Life Sciences. Before joining Lionbridge, she worked as a clinical trial manager and coordinator for pharmaceutical leaders Novo Nordisk, LEO Pharma and others.

Pia Windelov headshot

Pia Windelov

Pia Windelov is director of product strategy for Lionbridge Life Sciences. Before joining Lionbridge, she worked as a clinical trial manager and coordinator for pharmaceutical leaders Novo Nordisk, LEO Pharma and others.

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t’s no secret, especially with the whole world currently focused on medical research, but clinical trials are complicated. And in a way, that’s a good thing. Drug development trials determine whether a drug is safe for patients and demonstrates benefits that outweigh any risks. By measuring how patients feel and function in their daily lives, clinical outcome assessments (COA) — a sort of report from these trials — provide quantifiable evidence pharmaceutical companies use to support the medical claims they list on drug labels. During a trial, timelines, patient impact and government regulation all combine into a myriad of data points to monitor. The most overlooked is translation.

By addressing linguistic nuance during protocol development, trial sponsors can ensure regulatory compliance, appropriate instrument use and improve overall COA performance, as well as play a vital role in helping corporate business units inevitably launch drugs into new markets. But none of this happens if translation is inaccurate — not just regarding multinational trials but also domestic ones with limited-English proficient (LEP) patients in the United States, for example. This accuracy isn’t just vital for COAs themselves, but across all trial documentation.

Working with experienced translators is an obvious fix, but organizers must also choose the appropriate translation methodology. In an industry where regulations constantly change, costs consistently rise and corporate leaders are always demanding quicker timelines, localization can sometimes feel like it’s one more thing to have to do. But instead of making trials more difficult, the right translation management strategy actually helps patients and administrators avoid confusion, improves trial-wide comprehension, improves patient compliance and increases retention rates. Together, these factors result in better data collection and more precise trial conclusions. In short, translation helps assure a more effective trial.

So how can your company make it happen? Applying translation to The Professional Society for Health Economics and Outcomes Research (ISPOR) guidelines, we use a handy-dandy list of the top eight steps all trial sponsors should follow to ensure translation quality, guaranteeing content adherence between original and target COA and enabling trial researchers to compile outcome data while satisfying regulatory requirements:

1 Get your words straight. For training documents — just like any other pharmaceutical translation — accuracy is essential. After all, if raters and patients don’t understand training videos, interactive didactics and other trial materials, they won’t know how to properly administer COA measures. When training information is incorrect, work gets even harder for team members out on trial sites. It makes studies longer and more expensive too. So start by reviewing all trial-specific concepts referenced in the source with your translation team. A thorough glossary and termbase will strengthen conceptual equivalence for every language.

2 Buy your own translations. Administer so many of them and clinical trials can begin to look alike. But they aren’t. Every trial and every drug is different, deserving its own specialized attention. Its translations should be unique too. Yes, linguistically-validated translation of common COA instruments already exist, but unless they’re yours, don’t use them. Just because content is on the web doesn’t mean it’s open source; the copyright holder controls the distribution of that translation and using it without authorization may violate copyright protection, costing your company far more than you’re trying to save. With so many licensing variables in play, the smarter decision is to streamline source content in order to maximize translation memory (TM) leverage. Save on your own content by writing in a way that maximizes matches, then ask your translation partner to start building a TM with the very first word.

3 Double up on quality. Start by contracting two pharmaceutical specialist translators who independently localize documents into the participant language and culture. Then contract a qualified, objective third party to evaluate their translations, compiling the two into a single document for the best possible standalone translation.

4 Back translate. Without giving them a copy of the original source document, the glossary or other files, ask a new, qualified translator to back translate. Compare this back translation to the source in order to ensure correct meaning.

5 Now tweak it. Localize any language spoken in more than one country from one dialect to another. Compare different language versions of the COA, focusing on conceptual equivalence and local cultural nuance: Is the content still appropriate? How will it be received?

6 Perform in-country review. Engage a medically-qualified specialist to review clinician-reported outcome (ClinRO) and performance outcome assessment (PerfO) translations. This individual shouldn’t just check for medical and scientific term accuracy, but if there is room for misunderstandings, suggest alternatives.

7 Test it. As part of a cognitive debriefing interview, share patient-reported outcome (PRO) and observer-reported outcome (ObsRO) translations with a small group of patients who represent the trial’s target population. The goal here is to make sure they understand and to verify once again that translations are suitable and culturally relevant. A qualitative interviewing specialist should perform these interviews in each respective target country and each target language in person. This doesn’t just guarantee linguistic quality. It also serves as regulatory evidence that the original instrument and its translations align.

8 Save your work. Going back to the importance of that translation process, prepare a final report on the linguistic efforts that the company can provide on request to government and industry regulatory bodies.