Best Localization Practices For Global Clinical Trials
For the last month, I have been logging every day into the Luscii app on my smartphone and sending my health data (cough yes/no, sneeze yes/no, temperature, pain in my chest yes/no) to the OLVG Hospital in Amsterdam, the Netherlands. Within a few hours, I receive a message that says that I am fine - for the moment, fingers crossed - and that I am to keep following the guidelines issued by the local authorities to fight the COVID-19 pandemic. If I start experiencing the above listed symptoms, a tap on the “Contact” icon will (hopefully) put me in touch with a doctor.
A few years ago, this would have been unthinkable - and, to many of us, unacceptable if we consider the privacy issues. But, like it or not, the COVID-19 coronavirus is rapidly changing every single aspect of our life as well the whole localization workflow in the life science sector.
This was also the first issue that was pointed out by the panelists who took part in the life science webinar organized by Wordbee to discuss best practices in the localization of global clinical trials.
What is a global clinical trial?
Simply put, a global clinical trial is a clinical trial meant to evaluate the effectiveness and safety of a medication, a medical treatment or a medical device by monitoring its effects on large groups of people worldwide.
There are many good reasons for running clinical trials across various countries. For example, some countries may be able to recruit participants faster than others; or the trial could focus on a rare health event, such as the zika virus, making it necessary to enroll many centers in various locations, each one recruiting just a few patients to curb the duration of the trial.
In addition to this, to prepare a license application as well as ensure that the product is safe and that it works in the same way in different patient groups, clinical trial data needs to be collected from varied populations.
Logistics are also crucial. The participating countries should be chosen based on criteria like their national health system and information system structure (for example, whether the system offers quick access to patients), treating regimens, and patient population.
Localization target groups
The translation of medical information also comes into play from the onset of the trial. Documents include, among others, study protocols, investigators’ brochures, patient informed consent, clinical study reports, patient narratives, and all texts that need to be localized in a meaningful way for the various stakeholders with a global clinical trial.
The main stakeholder is of course the patient group. It is necessary to find the right language to convey the clinical trial information based on the various patient backgrounds and the knowledge that they may or may not have about the research.
Other stakeholders are the biotech companies and patients advocacy groups, in addition to local sponsors, prescribers and investigators, doctors and nurses and, last but not least, the coordinators responsible for the protocol.
For each group of stakeholders, the localization team will have to use the right combination of medical, legal and standard vocabulary in the target language.
Main localization steps
Within the actual localization blueprint, our panelists highlighted three essential actions.
First, it is necessary to ensure the cooperation with linguists in order to build or update a glossary and get the candidate list validated by the client/subject matter expert. Translation memories must also be created/aligned or updated to ensure consistency.
A second necessary step consists in running a translatability assessment to see whether there are elements in the documentation that are untranslatable and need instead a full cultural adaptation. It is important to keep in mind that the same translated document will not serve different target audiences: investigators/clinical and patients documents require for example two different setups of terminology and text structure. Images, backdrops and marketing material are often culture-sensitive, too.
A third step consists in collecting these elements in the instructions for the entire localization team, together with localization guidelines, a style guide and reference material, if available, what is usually known as a localization kit.
We already wrote about the importance of back translation and linguistic validation. To these two very important steps cognitive debriefing is added.
Cognitive debriefing is an interview technique used in the development of patient reported outcomes, or PROs. The outcomes reported by the patient are essential to understand his or her point of view on a disease or therapy. This data cannot be collected by way of a clinical measurement, but is nevertheless important.
PROs must be carefully written to collect information that is important for patients. The wording of a question is of great importance: vague questions provide vague information. More specific questions about emotional well-being will provide more detailed information.
To test its clarity and completeness, a PRO should be tested linguistically with at least 5 participants. The interviewer - in this case a linguist/translator - asks participants to explain or rephrase some of the questions and statements presented in the document. This allows to identify any issues or missing nuances.
There is also a cultural component in all this. Our panelists reported that patients in some countries are not willing to answer personal questions. In such a case, it’s necessary to adapt or redevelop the PRO’s content.
Changes on the horizon
In a recent interview to the Dutch newspaper NRC Handelsblad, Jaap van Dissel, director of the Dutch RIVM (Netherlands National Institute for Public Health and the Environment), stated, “There will be so many innovations that I’m not gloomy about the future.” He was referring, among other things, to the use of apps by South Korea and other countries to trace infected persons.
The point is that there is no answer for now to the question: How will COVID-19 disrupt the localization workflow of medical documentation? The panelists reported, for example, that a good number of clinical studies have now been cancelled while attention shifts to the development of a vaccine for the new coronavirus. Other changes that will have to be considered very soon will affect patient access: How can research be brought into patient’s houses in a protected way? Which digital solutions do we need to collect data about clinical trials? Or do we need to develop new ones to monitor patients’ health remotely? Or, again, maintain doctor-patient communication?
The current situation leaves us with many challenges that have yet to be solved. In the meantime, we invite you to watch the recorded panel webinar.
Wordbee Translator is a translation management and linguistic tooling system. We have developed special features for customers in enterprise sectors like life sciences, gaming, tech, and media. Click here to watch a video on how linguistic validation processes can be handled in Wordbee Translator.