Why linguistic validation is becoming integral in maximising the patient voice

Few would argue that the trend over the last decade or so to listen more to the patient voice has been a positive development. Life sciences firms have now recognised the importance of listening to target populations much earlier in the product planning, research and development lifecycle. This is reflected in the growing emphasis on strategies such as observational research, focus groups and social listening for trying to understand what patients need and want at a far earlier stage.

As well as portraying the company as more patient-centric, this gives sponsors a chance to develop more of what the market wants and needs, and to hone their clinical trial activities. The more they understand about a condition and patients’ experiences up front, the better chance they have of developing something that will significantly improve outcomes.

But patient groups are increasingly international, and crucially, multi-lingual. To maximize the value of such patient focus groups and other early-stage initiatives to capture the patient viewpoint, life sciences brands and contract research organizations (CROs) need an effective way of making this consistent across different nationalities and cultures. This is why linguistic validation has grown so important when listening to the patient voice.

More than translation

Linguistic validation is a finer art than mere translation, going beyond accurate use of local language, spelling and grammar, to ensure that the points of reference used in assessments are culturally relevant to the target audience, so that COAs count as viable supporting evidence for trials.

Researchers have recognised the importance of asking patients targeted questions assessing the effects of the condition on their ability to function day-to-day. Instead of asking patients to rate their pain on a numerical scale, more relevant data is obtained when patients are asked what their pain prevents them from doing. As daily activities vary around the world, the cultural adaptation of these questions becomes critically important for the valid analysis of pooled data across languages and cultures.

So if the COA’s area of interest is to assess patients’ shoulder mobility, and an original option for describing this is ‘I am able to shovel snow’, the translation challenge is not simply to convert this to the local language, but to consider too whether this statement has global application. Since large parts of the world do not experience snow, a literal translation will not suffice – otherwise it will yield high instances of ‘don’t know’ or ‘not applicable’ responses in those markets.

Controlled cross-cultural adaptation

Truly effective linguistic validation involves controlled cross-cultural adaptation. Where given criteria are met (‘hot climate in target locale/ no snow’), the team would adapt the source statement to an accepted equivalent to maintain a consistent response. So in regions with persistently warm climates, ‘I am able to shovel snow’ is changed to ‘I am able to lift heavy grocery bags and place them on a counter’ in the target language.

A more subtle example but just as important, would be the ability to differentiate between different responses to or definitions of quality of life. So when assessing the impact on self-perception of patients undergoing treatment for breast cancer, teams are aware that ‘I am embarrassed by my appearance’ could mean the same as the statement ‘I am self-conscious about my appearance’ in another culture.

COAs and the progression of clinical trials

The majority of companies struggle with such granularity, because their designated teams lack the awareness or training to recognise the issues, and/or make appropriate judgement calls (in partnership with trial sponsors) to shore up the value of international COA data.

Yet COAs are critical to the progression of clinical trials. And, although there isn’t a legal requirement for standard approaches to translation and linguistic validation, the major health authorities – certainly EMA, FDA and PMDA in Japan – support best practice in the interests of quality and patient safety.

Linguistic validation is inexpensive and the word counts are not typically onerous, so this shouldn’t be a difficult situation to address. More often than not the issue is a practical one: (a) failure to consider the requirement early enough in the cycle to allow the time to manage it, and/or (b) a lack of internal capability.

But that’s where a specialist language services provider can help, able to uphold the integrity of patient feedback and ensuring that the patient voice is listened to and its value is maximised.

About the Author

Dana Weiss is Director of Linguistic Validation and Customer Services Manager at AMPLEXOR, a leader in medical translation for medical device, pharmaceutical, biotech and CRO organizations worldwide.