Patient-focused communication in multilingual clinical trials

It should come as no great surprise to read that the results of clinical trials have a long-lasting impact on patient care and that the reliability of any given study is therefore imperative. Effective communication is key to ensuring patient comprehension and thus the credibility of study findings. Multinational and multilingual clinical trials – which are becoming increasingly common in a bid to speed up patient recruitment and secure national agency approvals – throw up interesting challenges in this respect.

Expanding the geographical and/or linguistic scope of your clinical trial helps to ensure greater diversity amongst your patient population. This is particularly important given the varying prevalence of adverse drug events (ADEs) from one ethnic group to another. Being able to demonstrate to medical agencies that your patient population is representative in terms of race and/or ethnicity serves only to bolster the credibility of your findings, whilst of course helping to avoid racial and ethnic disparities in the very foundations of your work.

What’s more, putting your patient-facing materials out there in multilple languages helps you find the necessary number of participants faster. It boils down to a simple equation – the  wider the net you cast, the quicker you will be able to locate the necessary individuals. The relevance of this is especially clear when we consider trials involving orphan drugs, for which the available pool of participants is naturally limited. For rare diseases, you may in fact have no other choice but to take your clinical trial to an international level.

Besides this, however, it comes down to a question of trust: Most individuals would feel more comfortable agreeing to partake in a trial if everything is explained to them in their first language. We must not forgot that trial subjects are human – and human connection is most easily established when you’re fully equipped to understand and discuss the topic at hand. Providing clinical trial materials such as questionnaires and informed consent forms (ICFs) in patients’ native languages helps drive patient engagement and retention – the latter being all the more important if the study is expected to last a long time.

From a safety perspective, patients are most likely to truly grasp the risks and benefits involved in a trial when presented with information in their mother tongue. This, in turn, ensures the trial sponsor is compliant with their patient safety requirements. Communicating with trial subjects in their native language also means patients are less likely to misunderstand instructions and protocols whilst being better able to describe their experience. As a result, trial sponsors benefit from more honest and in-depth Patient-Reported Outcomes (PROs). Indeed, it is for good reason that EU regulation 536/2014, Section (30), dictates that “prior to obtaining informed consent, the potential subject should receive information in a prior interview in a language which is easily understood by him or her.”

Most countries will, rather understandably, stipulate that you need local versions of your materials. As per German legislation, for example, authorisation is required from the competent Ethics Committee. As part of the application process, information must be provided in the German language, notably including the information and documents given to the trial participants. In France, there are very few documents that can be submitted in English only, particularly with regard to Part II of the Clinical Trial Application (CTA), for which only the investigator CV and declaration of interest are not required in French. Getting your clinical trial collateral translated upfront will help streamline the process and cut down on back and forth with local regulatory stakeholders.

When it comes to translating in a clinical trial context, accuracy is crucial. Simple mistakes can have a huge impact on patient safety, the credibility of the trial, and ultimately the regulatory agency’s decision to approve the medicinal product. The safest method of avoiding such mishaps is what is known as Linguistic Validation (LV).

An intrictaley structured process, Linguistic Validation involves multiple rounds of translation and revision by specialised linguists, patients and clinicians alike. The content subject to translation and revision are known as Clinical Outcome Assessments (COAs), i.e. evaluations of the patient’s experiences and the performance of the medical treatment. With its multiple rounds of quality assurance and conclusive certification, Linguistic Validation prevents a disconnect in communication between patients and the trial sponsor team, thereby helping to avoid unncessary hiccups.

First Edition Translations collaborates with CROs, pharmaceutical manufacturers, university hospitals, and MedComms agencies across the globe. Within our ISO-certified framework, our multilingual project managers work alongside our specialised life sciences translators and linguistic validation consultants to ensure optimal quality across the board. We’ve been in the business since the dawn of the 80s – and for good reason. Whatever the size of your project and whatever languages you require, we are happy to discuss your needs under enquiries@firstedit.co.uk