Written by: Kayla Gade, MATLM ’25
As a student interested in the life sciences space in localization, one area that has consistently caught my eye is clinical trials. Since localizers are inherently part of accessibility, I have always felt that they play an important role in maximizing humanitarian justice within clinical trials while minimizing exploitation. From my experience at Middlebury Institute and within other localization communities, life science in general does not seem to be a well-known space, nor one that a large number of people actively pursue from the start, so I feel it’s important to make sure localizers of all stripes are aware of this field and important role that we play. Today, we’ll explore a bit about clinical trials.
There are a multitude of challenges within clinical trials that lend themselves to injustice toward people that localization professionals serve, but a couple that I would like to mention for today’s article are these pieces of information, focusing on trials within the United States:
Overrepresentation in Phase I Clinical Trials:
Phase I clinical trials are first-in-human trials of a drug and primarily assess safety, dosage, and pharmacokinetics, so they often involve recruiting healthy volunteers rather than patients. Financial incentives play a role, and emerging evidence suggests that economically disadvantaged individuals, particularly from minority communities, are overrepresented.
Underrepresentation in Later-stage Clinical Trials:
While minorities are overrepresented in Phase I, first-in-human clinical trials focused on safety, they often find themselves underrepresented in later-stage trials that could provide significant therapeutic benefit, due to a lack of adequate outreach in languages that these potential participants can understand as well as the perceived burden on researchers of needing language support for these individuals.
The challenges of underrepresentation and exploitation in clinical trials are deeply tied to language and cultural barriers, making localization professionals critical allies in addressing these issues. Clinical trials often require precise communication across diverse populations, from recruitment materials to informed consent forms, to ensure participants fully understand their rights, responsibilities, and the trial procedures.
How can Localization Professionals Help?
- Localization professionals can advocate for and facilitate the use of plain language in the original study materials. Creating clear source content makes the subsequent translation process more effective and reduces the risk of misinterpretations across different languages and cultures.
- By ensuring clear and culturally appropriate communication, localization professionals help to mitigate the therapeutic misconception, where participants may confuse research participation with receiving standard medical treatment.
- Localization professionals are essential for providing accurate and culturally sensitive translations of critical trial documents, particularly informed consent forms. Some participants join trials for the money without an adequate perception of any risks involved – we can help them understand these risks.
- Effective localization goes beyond mere linguistic translation to encompass cultural adaptation of study materials. This involves ensuring that the language used is appropriate for the local context, considering cultural norms and sensitivities to build trust and enhance understanding. There is another layer of this for overseas clinical trials, which we will explore in a later article.
- Support the work of qualified medical interpreters who possess both linguistic proficiency and an understanding of medical and research terminology, as well as ethical considerations, to ensure effective real-time communication with participants who have limited proficiency in the study language.
We will explore other facets of the localization world within clinical trials as well as in other areas of life sciences in further articles. Stay tuned!
