Clinical trial considerations: Why localisations matter...
Since 2016, we have delivered clinical trial support materials:
- spanning 30 different disease areas
- to over 40 countries
- in more than 70 languages
- reaching over 110,000 clinical trial patients
And we certainly won’t be stopping anytime soon, because translating and localising content is a key part of all clinical trial communications.
Whilst it may seem obvious that we need to translate content for international clinical trials, it is also important in local trials too, and is especially key in geographical areas where many different languages are spoken. Why? Because the ability to access health information in a format that patients can understand is core to health literacy and has a significant impact on clinical trial retention and health outcomes.
So, what should we be keeping in mind when localising materials for a clinical trial?
Firstly, materials should always crafted with health literacy in mind. Want to know more about how we approach health literacy? You can read about it here. But in a nutshell, the words, layout, colours, as well as icons and images, should all be carefully selected to maximise understanding for patients.
Exploration of cultural sensitivities that may create barriers to recruitment and retention is really important, which is also where co-creation with patient groups can really help in making sure that messaging is tailored, and suitably explained.
There’s no room for error in clinical trials so working with specialised translation agencies is essential in ensuring that every message is delivered to the same standards, no matter the language.
From a practical perspective, different languages take up differing amounts of space on a page, so if a clinical trial requires materials in more than one language, optimising print layout is crucial to the efficiency of the project and its budget.
Did you know that translating from English into most European languages takes up an extra 10–35% of space1?
Last and by no means least, countries may have different guidelines that they need to follow or varying regulatory bodies to satisfy. For example, in the EU/EAA all clinical trial applications must be submitted via the Clinical Trials Information System (CTIS). This is why, no matter where a clinical trial is located, it’s important to make sure that materials are ready for local regulatory approval.
Localising clinical trial materials across the board really does make a difference, and in our experience, supports clinical trial success. So, if you’re feeling lost in translation with your clinical trial project, then let’s talk.
You can read all our latest clinical trials explained blogs here.
