Linguistic validation, as seen in the first part of this two-article series, describes a set process for accurately rendering clinical trial content, especially clinical outcome assessments (COAs) and patient-reported outcomes (PROs), into other languages. Following this process is essential to ensure linguistic equivalency and cultural appropriateness, which are indispensable for collecting reliable data.

However, even the best process will not yield the desired results if poorly executed. Who are the people and partners you need to bring on board for your LV project to work seamlessly and produce the desired outcomes?

Who you need

If you look at the handy flowchart in our first article on LV, you’ll see that every stage of the process requires specialized personnel with specific expertise. You may have some of these in-house, such as project owners, project managers, clinicians, and reviewers. However, at its core, LV is a translation and linguistic adaptation process that cannot succeed without the deep linguistic and cultural expertise that only expert professional translators, editors, and proofreaders with broad cultural insights and professional-grade language skills can provide.

At a minimum, you will need two translators for the forward translation, one linguistic expert for reconciliation, and a third translator for the backward translation. Additional translators or linguistic consultants may also be required for review, reconciliation, harmonization, cognitive debriefing, and final review. Working with multiple languages and language variants naturally multiplies the number of project stakeholders.

These experts need to have highly specific knowledge and experience to support your LV process successfully, including:

• Professional translation expertise
• Native fluency in the target language
• Expertise in the respective therapeutic area
• Knowledge of statistical and other scientific concepts
• Cultural expertise relating to the target population and region
• Knowledge of the LV process and its steps and goals
• Ability to use project-specific software and tools

Specialized Requirements

How do you evaluate whether potential project partners have the necessary expertise and qualifications? With so many variables in play, partnering with an experienced language service provider (LSP) with all the necessary resources can be helpful.

To evaluate whether project stakeholders are well-positioned to help with your LV project, consider the following criteria:

Are they native speakers of the target language?

Precision, tone, and cultural competency are essential for LV projects. Native speakers of the target language should be preferred, as they can bring their innate understanding of culture, context, and idiomatic language to a project. This knowledge will ensure that the translation resonates with your intended target audience.

Note: In LV, paying attention to language variants is particularly important. Just as having a text written in British English might not resonate with or be jarring to a speaker of US English and vice versa, a native speaker of Castilian Spanish as spoken in Spain will not have the required expertise to produce content in the form of Spanish spoken in other regions of the world.

Do they have an excellent grasp of the source language?

In addition to being native speakers of the target language, your translators and reviewers must be highly proficient in the source language (the language your original content is written in, often English) to grasp every nuance of meaning. Ideally, look for experienced professionals with qualifications such as degrees in translation and certification or accreditation by recognized associations or bodies. The same applies to subject matter expertise, especially in complex life sciences topics. If you are not multilingual yourself, it may not be immediately apparent that the required expertise goes far beyond what can be gained during a few months or even years of language learning or living abroad.

Are they qualified professionals?

For those not versed in a specific language, it may be easy to think that anyone who can speak or write a language – especially if it’s their native language – should be able to translate and adapt content. Translation and cultural adaptation are particular skill sets independent of knowing a language well. If this is difficult to picture, imagine the difference between reading a well-crafted piece by a professional writer vs. content written by someone who hasn’t written much since they left school to approximate the effect. Ideally, look for credentialed translators who have completed specialized training such as graduate degrees in translation or been certified through reputable organizations who are themselves members of the International Federation of Translators (FIT) such as the American Translators Association (ATA) or the Institute of Translation and Interpreting (ITI) in the UK. A complete list of FIT member organizations is available here.

Do they have subject matter expertise?

No matter how good a translator, editor, proofreader, or project manager may be, a life sciences project relating to patient-centered outcomes on various conditions needs to be handled by someone capable of fully understanding and rendering the medical and scientific content and concepts. Without a good understanding of the topic, errors and differences in register or issues with consistency may arise. While finding someone who is an experienced language professional and a medical professional would be ideal, a scientific degree is not necessarily required. Other indicators, such as experience in a therapeutic area and ancillary qualifications, should be looked at in these cases.

Are they linguistic validation experts?

LV is a very unique type of translation and adaptation process. It is more complex than a standard translation. It also involves many stakeholders and requires a deep understanding of the individual’s given role in the process and the unique requirements of each step. Balancing precision with cultural and conceptual sensitivity in the forward translation and reconciliation processes and adhering to a strict verbatim rendition during back-translation are unique requirements of the LV process. Your partners will need to comprehend and adhere to these fully.

Finding the right experts for your project

Where, then, can you find these experts? You could go out and try to recruit them yourself. However, this necessitates careful planning: Who will manage the project? What about translators and linguistic consultants – how will you ascertain their competency and the quality of the results? Do you have employees capable of doing some of the work or at least assessing quality? It is important to remember that the results of the linguistic validation process and the work of those involved directly impact the reliability and validity of patient-reported outcome data, so choose your team wisely! An honest assessment will give you the necessary insight on whether you can manage this in-house or your organization may be better off outsourcing some or all of these project steps to an external provider.

Partnering with LSPs

This situation is where a specialized language service provider (LSP) comes in: These organizations have the resources – from linguists to project managers, the process capabilities, and the linguistic validation expertise to not only handle your project but also do the legwork of selecting, allocating and managing the best-qualified professionals for your specific project. Unless you have the resources, the know-how, and the expertise – or are willing to develop them – this is often the most effective solution, especially if you do not handle this type of project regularly.

AI and LV

In this day and age, you may be thinking: Why not just have AI do it? Wouldn’t that help me achieve the best, most consistent—or at least sufficient—quality? Even though AI, chatbots, and machine translation (MT) have made tremendous strides lately, in addition to privacy concerns, these technologies cannot replace human expertise and cultural sensitivity.

While AI can rapidly process tremendous amounts of data, including language data, processing does not equal understanding. Comprehending context, connotations, cultural references, emotion, and nuance requires human expertise, as does cultural sensitivity and in-depth knowledge of literacy levels and appropriateness. Furthermore, AI risks introducing bias and stereotypes depending on the content it may be trained with.

AI also generally does not perform well when it comes to consistency. While humans can fix this issue, regional language variants are another situation where AI does not shine. Finally, there is the crucial topic of privacy. When using a generic AI tool, your content is fed into the tool, raising serious concerns about privacy, data protection, and the integrity of your research.

Takeaways

Linguistic validation (LV) is a carefully crafted process to ensure your project’s success. Done well, it is an invaluable tool for ensuring conceptual equivalence, accuracy, and cultural appropriateness. When working with PROs and COAs, a successful LV process holds the key to gathering high-quality data and scientific rigor, regulatory compliance, and privacy. However, as with any process, no matter how well designed, it only works when you have the right resources and partners.

Experienced Language Service Providers (LSPs) with the requisite capacity and expertise can help you bring these projects to fruition. With a pool of specialized resources such as experienced LV project managers and well-qualified language professionals with subject matter expertise, they can ensure your projects succeed even when they contain complex medical content and involve multiple languages, language variations, or even rare languages. They also have rigorous quality assurance processes to verify accuracy and eliminate ambiguities to ensure data quality and scientific integrity.

Finding the right team and properly managing the process will go a long way toward a successful LV outcome. Contact Vistatec today to talk about your next project.