Amplifying the patient voice and the role of linguistic validation

Virtually everyone and anyone in life sciences, from regulators to patient advocacy groups, agree that patients should have greater input in the drug and medical device lifecycle and should also have the opportunity to do so much earlier than they have done to date. It’s vital for both pharma and CROs to capture international feedback consistently so that they can rely on it to shape their planning. AMPLEXOR’s Dana Weiss explains why linguistic validation is a critical element of this process.


iven that drugs are generally designed and manufactured in order to make patients better, improve their quality of life, prolong their life and much more, it has taken a curiously long time for the life sciences sector to become patient-centric. But the last decade or so has finally seen this shift, and the patient voice is now as vocal and valued as it ever has been.

Life sciences firms want to be seen as being more responsive and receptive to what patients are saying. They also want to differentiate their portfolios in new and more effective ways, so these life sciences companies have accepted 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 observational research, focus groups, social listening and broader real-world data as strategies for trying to understand what patients need and want at a much more embryonic stage.

This is important for a number of reasons. It portrays the company in question as being patient-centric, an important quality in a world where the patient voice is seen as more important than ever before. Furthermore, it also provides sponsors with the opportunity 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 of that condition, and the earlier they have that information, the better chance they have of developing something that will significantly improve outcomes.

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 organisations worldwide.

The global nature of life sciences

But life sciences is a truly global industry in 2018, and manufacturers sell drugs all over the world. So to really maximise the value of international patient focus groups and other early-stage initiatives to capture the patient viewpoint, life sciences brands and contract research organizations (CROs) need a reliable way to make this consistent across different nationalities and cultures. The overall goal is to have clinical outcome assessments (COAs) completed in one part of the world equivalent and comparable to those completed in another.

This is far more than a translation task: it requires the finer art of linguistic validation. This goes beyond the accurate use of local language, spelling and grammar – which should be a given anyway, given the importance of accurate translations in life sciences – and should also ensure that the points of reference used in assessments are culturally relevant to the particular target audience, so that COAs count as viable supporting evidence for trials.

Researchers have recognised the increasing importance of asking patients targeted questions.

Researchers have recognised the increasing importance of asking patients targeted questions that assess the effects of the condition on their ability to function in their daily lives. Asking patients to rate their pain on a numerical scale does not always deliver the most relevant data, so a better and more effective approach would to ask those patients what their pain is preventing them from doing. As daily activities vary so dramatically in different countries and from culture to culture, the cultural adaptation of these questions becomes hugely 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. These in turn would skew the international picture, threatening the value of overall patient findings.

What constitutes smart linguistic validation?

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. This would mean that 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.

Other cultural considerations might include the local diet, if the subject of the COA is digestive disorders. Here, the original Western statement, ‘I am able to eat soft foods such as mashed potatoes and oatmeal’ might be adapted to ‘I am able to eat soft foods such as rice and khichdi’ further east. Even more subtle, but just as critical, would be the ability to differentiate between different responses to or definitions of quality of life.

So that, 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 be equal to the statement ‘I am self-conscious about my appearance’ in another culture.

The importance of effective listening

The majority of companies struggle with this granularity of global patient evidence capture. Typically this is 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.

Although there isn’t a legal requirement for standard approaches to translation and linguistic validation, the major health authorities support best practice.

Linguistic validation is inexpensive and the word counts are not typically onerous, even with the rising interest in proactive early patient consultation, 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.

This is where a specialist language services provider can really add value – knowing exactly what to look out for, and able to make informed recommendations to firms or CROs, upholding the integrity of patient feedback and ensuring that the patient voice is properly heard and amplified effectively when it is needed the most.