The Importance of Taking a Holistic Approach to Localization in Your Trial

Posted by Tom Guckian on Oct 15, 2018 12:13:32 PM

Clinical trials are unarguably a global endeavor, with protocols often being developed in one country but subsequently implemented at sites throughout the world, in multiple languages and across diverse cultures.

Clinical trial design must take into account, not only the regulatory requirements in other countries, but also, the medical conduct specific to those countries, meaning that any study materials - investigator brochures, clinical trial protocols, Clinical Trial Agreements (CTAs), Informed Consent Forms (ICFs) and Patient Reported Outcomes (PROs) – must be accurately translated into all local languages relevant to a trial.

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The Challenge with Medical Translation

Of course, translation of clinical trial documentation requires exacting attention to detail, not least because the consequences of misinterpretation are potentially very serious. At best, your ability to recruit or retain patients might be compromised; at worst, deviations from the protocol could lead to adverse events or even loss of life.

Yet, despite the critical role it has to perform, translation is often not fully incorporated into global trial design. In a study that analyzed the readability of translated informed consent forms used in psychiatric clinical trials, it was found that most informed consent forms were ultimately too complex to be understood by an average adult subject.


Taking a Holistic Approach to Localization

At Longboat, we are always considering our audience, the end-user. The needs of that audience– patients and health professionals – become even more important when they are located in a different country.

Generally, there is an assumption that research staff in other countries are able to read and write English at a basic level. However, clinical trial documentation can and does involve highly technical content, and the various audiences interpreting such content must be taken into account.


Finding a Trusted Partner

Medical language is a minefield, filled with countless euphemisms, medical eponyms, acronyms, and synonyms! Add to that the translation of various drug names and brands, and it’s clear to see why translators must not only have native fluency, but must also be familiar with medical terminology and able to account for any cultural nuances in clinical trial communications.

Identifying a trusted partner who uses subject matter experts for localizing all patient and study materials, and can operate at scale, will guarantee accurate communications that are fit for purpose at any site anywhere in the world.

Another key consideration includes choosing a partner with the capacity to carry out efficient translation across multiple sites, ensuring that the process doesn’t become a trial bottleneck.  Expert medical translators utilize tools, such as centralized Translation Memory (TM), which eliminate any redundancy in terminology and phrasing, thereby reducing the overall cost of translations.

Proactive clinical trial teams who take a strategic approach to translation, tend to establish a clear process that incorporates clinical review stages as well as pilot-testing to understand how well patients understand the information presented to them.

Indeed, this model for quality assurance in medical translation outlines three stages of translation with their critical areas, which need to be secured in order to meet adequate medical translation quality requirements.


In Summary

  • Trial content for patients must be translated into their local language to ensure optimal engagement and clinical trial compliance
  • Assuming that site teams can carry out this translation on your behalf is inadvisable, and could jeopardize not only your trial’s success but patient safety also
  • Partnering with expert medical translators ensures that meaning is not lost in translation
  • Taking a holistic approach to localization – ensuring that all trial information takes into account local language and culture – undeniably leads to trial success


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Topics: Clinical Research Conduct, clinical trial training, clinical trial technologies, Clinial trial sites

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