Medical Device Translation for Global Clinical Trials
The global clinical trial market is expanding and is projected to reach a valuation of USD 106.78 billion by 2032. To achieve the best results in clinical trials, involving participants from diverse backgrounds requires accurate medical device translation.
Let’s learn about medical device translation, how it enhances the accessibility of clinical trials, and trending practices worth consideration.
Clinical Trials and Medical Device Translation
Clinical trials have standard procedures categorized into multiple phases. All the phases include uses of medical devices that vary as per the trial purpose. For instance, a global clinical trial of insulin pumps for diabetes management can have participants from diverse countries.
All the participants need accurate information in their native language to understand the purpose of the trial. Also, clinical researchers and healthcare professionals coming from diverse backgrounds need accessible medical information in their preferred language.
Medical Device Translation and Accessibility
Here’s how accurate medical device translation ensures accessibility for clinical trials addressing diverse participants:
Making Instructions Easy to Understand
Participant accessibility in clinical trials begins with clear instructions in a language they understand. When trials involve speakers of different languages, translating User Manuals, Instructions for Use (IFU), Labeling, Quick Reference Guides, and Training Materials ensures participants know exactly how to use the device and follow the trial rules.
Providing materials in their native language makes participants feel more comfortable joining the trial and builds trust. By removing language challenges, researchers can add more participants and expect better results.
Customized Translations for Better Compliance
Using medical devices isn’t the same for everyone, especially when cultural habits differ. Customizing translations to fit local languages, phrases, and cultural differences helps instructions feel more familiar to participants, leading to better compliance.
When people can relate to the instructions, they are more likely to follow the rules properly, which leads to better data quality and helps the trial run smoothly. For instance, if people have a local term used for some device, it’s better to use that instead of sticking to the standard terminology.
Making Low-Literacy Participants Understand
Some participants may find medical terms confusing, making it hard to use the device correctly. Translations that are simple and clear can help everyone understand what to do, irrespective of their reading level.
Transforming complex terms into everyday language and using visual aids, like diagrams and flowcharts makes it easier for participants to follow instructions. This approach keeps everyone safe and makes the trial more comprehensive
Ensuring Participants Know It All
In clinical trials, informed consent is essential, especially for participants with Limited English Proficiency (LEP). Translating consent forms, trial details, and safety procedures ensures LEP participants understand the risks and benefits, safeguarding their rights and enabling diverse participation.
Compliance with Institutional Review Board (IRB), Good Clinical Practice (GCP), and Health Insurance Portability and Accountability Act (HIPAA) standards requires translating key documents like device information, safety protocols, and training materials. Accurate translation and thorough documentation support informed decisions and clear communication throughout the trial.
Encouraging Remote Trials
Remote clinical trials offer numerous benefits, including increased participant accessibility, reduced costs, and enhanced data quality. Digital technologies expand the participant pool and boost efficiency.
Successful remote trials rely on innovative tools like telehealth platforms, mobile apps, and secure data-sharing solutions. Regulatory compliance is crucial, with adherence to FDA guidelines, EU regulations, and HIPAA standards. This streamlined approach transforms the clinical research landscape, making trials more accessible worldwide.
Best Practices for Accessible Medical Device Translation
Once you are well-versed in the fact that accurate medical device translation adds to accessible clinical trials. Here are some practices that can be considered:
Get Experts Involved From Scratch
Translation should be a part of the plan from the initial stage. Collaborating with expert medical translation service providers from the start ensures all documents are ready for different languages from day one. This ensures quality and consistency throughout the trial.
Use Simple Words and Pictures
Medical terms can be confusing. Using simple language helps participants understand. Adding visual aids, like infographics or translated video tutorials, makes instructions clearer and easier to follow.
Check For Consistency At Every Stage
Keeping an eye on every document and ensuring every word is as accurate as it should be is to be done by a medical expert. Translated materials and accessible formats expand trial reach. This includes underserved populations. Accessibility complies with ICH-GCP guidelines
Adapt Content to Fit the Culture
Translation isn’t just about words, it’s equally about aligning with the cultural contexts. Culturally sensitive approaches boost participant engagement. Diversity and inclusion ensure representative data. This meets Food and Drug Administration (FDA )regulatory requirements.
Keep Translations Updated Throughout the Trial
Clinical trials change, and so do the documents. Effective communication, cultural relevance, accessibility, and support drive trial success. They ensure reliable results and regulatory compliance. This benefits sponsors and Contract Research Organizations.
The Bottom Line
Medical device translation is a notable trend in the healthcare industry, enhancing clinical trial accessibility. It promotes inclusivity and boosts participation rates by ensuring that medical terms are understood in participants’ native languages, allowing clear responses.
At Datagain Connect, we provide affordable and secure medical translation services, ensuring that device-related documents are translated with the highest accuracy and delivered on time. Partner with us for a customized translation approach that adds accessibility to your project.
