There are several reasons behind this. 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, and realized that listening to patients earlier in the lifecycle - via observational research, focus groups, social listening and broader real-world data - is the smartest way of doing so.
This approach positions a manufacturer as being patient-centric. 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 translation of clinical outcome assessment (COA) measures – documents that gather the patient’s self-reports – is a critical step in ensuring the patient voice is heard accurately. This translation process is known as linguistic validation.
Life Sciences – a truly global sector
Life sciences is a global industry, where firms sell drugs all over the world. To maximize the value of international patient focus groups and other early-stage initiatives to capture the patient viewpoint, life sciences brands and CROs need to make this consistent across different nationalities and cultures.
This goes way beyond translation, and entails the finer art of linguistic validation, something that is a real specialism of the team here at AMPLEXOR. Linguistic validation ensures 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.
As daily activities vary so dramatically in different countries, the cultural adaptation of these questions becomes hugely important for the valid analysis of pooled data across languages and cultures. 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.
Smart linguistic validation
Smart linguistic validation should always include controlled cross-cultural adaptation, which is always front of mind at AMPLEXOR. Where given criteria are met (‘hot climate in target locale/ no snow’), our team will always adapt the source statement to an accepted equivalent. This would mean that in regions that are usually hot and don’t get snow, ‘I am able to shovel snow’ becomes ‘I can lift heavy grocery bags and place them on a counter’ in the target language.
Other cultural considerations might include the local diet, and even the ability to differentiate between different responses to or definitions of quality of life. For example, 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.
Struggling with global patient evidence capture
A great many companies struggle with this granularity of global patient evidence capture. This is often 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 by no means costly and the word counts are not typically onerous, even with the rising interest in proactive early patient consultation, so this should not be a difficult situation to address. Any issues are usually practical: (a) failure to consider the requirement early enough in the cycle, and/or (b) a lack of internal capability.
This is where a specialist content services provider such as AMPLEXOR can really add value. We know exactly what to look out for, and are able to make informed recommendations to firms or CROs. In doing so, we help the integrity of patient feedback and ensure that the patient voice is properly heard and amplified effectively when it is needed the most.