Prioritizing the Patient Voice


Applied Clinical Trials

AMPLEXOR’s Dana Weiss explains the critical role of linguistic validation in enabling the patients voice.

Patient advocacy groups, regulators, clinicians, and pharmas agree that patients should have greater input from much earlier in the drug and medical device lifecycle. Whether they have previously suffered a bad experience or want to more directly influence the products that come onto the market, it’s important that pharmas and CROs are able to capture international feedback consistently so that they can rely on it to shape their planning. AMPLEXOR’s Dana Weiss explains the critical role of linguistic validation in enabling this.

In their quest to be more responsive to patients, and differentiate their portfolios in new and more effective ways, 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.

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 to maximize 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 objective is to have clinical outcome assessments (COAs) completed in one part of the world equivalent and comparable to those completed in another. Learn more strategies on how to enhance clinical trial efficiencies at CBI's eCOA/ePRO 2018.

This is more than a translation task: it requires the finer art of linguistic validation. This goes beyond accurate use of local language, spelling, and grammar, also ensuring 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 recognized the increasing importance of asking patients targeted questions assessing the effects of the condition on their ability to function in their daily lives. For example, instead of asking patients to rate their pain on a numerical scale, far more relevant data are obtained when patients are asked what their pain prevents them from doing. As daily activities vary from culture to culture, 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. These in turn would skew the international picture, threatening the value of overall patient findings.

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.

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. Subtler still, 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, for example, 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.

Listening consistently

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 recognize 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, 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. But that’s where a specialist language services provider can help-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 when it counts most.


Dana Weiss is Director of Linguistic Validation and Customer Services Manager at AMPLEXOR.

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