5 Key Considerations for Clinical Trial Success

Language translation in clinical trials and the healthcare industry is more complex than many people may realize. Errors can range from amusing anecdotes to serious consequences, as seen when native Alaskans were mistakenly labeled as “polar bears” on medical forms in an emergency room. While this may, at first, seem quite humorous, the implications are serious, as lives are at risk.

Many people fail to grasp the intricacies involved in the translation process. While fluency in multiple languages and accurate conveyance of literal meanings are certainly important, it is just the tip of the iceberg. Beyond simply converting words from one language to another, effective translation in these industries requires a multifaceted approach that involves understanding the context, medical expertise, and cultural nuances.

Accurate translation in these industries necessitates not only linguistic proficiency but also subject matter expertise to ensure that crucial information is conveyed accurately and appropriately. Translators must also be aware of the potential impact of their translations on patient safety, regulatory compliance, and the overall success of clinical trials or medical interventions. 

This outlines why working with an effective translation service in high-stakes sectors like clinical trials, biotechnology, and healthcare is important. We must employ qualified professionals with specialized knowledge and compliance with rigorous quality assurance processes to mitigate the risks associated with language barriers.

Today’s article will look at five crucial considerations when choosing a translation expert for clinical trial documents. 

1. Expertise in Target Language and Cultural Contexts

Your first priority should be determining whether the chosen translation service provider has a profound understanding of the target language. For instance, if you need a consent form translated into Armenian, the translator should be capable of accurately translating it. It’s also important to confirm their understanding of the cultural nuances and regional differences associated with the language. This depth of knowledge goes beyond basic fluency and guarantees that the translated content effectively conveys the intended message.

2. Specialized Knowledge of Clinical Trial Subject Matter

Beyond language skills, it’s crucial for translators to have expertise in the specific subject matter, such as clinical trials. This includes understanding medical terminology, procedural details, and industry-specific nuances. This ensures accuracy and relevance in translations. To assess their competency, review their credentials and previous experience in similar projects, and inquire about their familiarity with the complexities of clinical research.

3. Compliance with Ethical Standards and Regulatory Guidelines

Ethical compliance, particularly with Institutional Review Board (IRB) standards, is crucial for conducting clinical trials responsibly. The translation service provider should have a clear understanding of IRB requirements, including maintaining confidentiality and respecting participants’ rights. The translation process must meet these ethical considerations to maintain the integrity of the clinical trial and protect the wellbeing and rights of participants.

ISO certification is another important consideration. Ask about the company’s ISO certifications to ensure they meet industry-recognized quality benchmarks in their translation services. These certifications demonstrate adherence to standards and quality control processes essential for accurate clinical trial documentation. 

4. Stringent Quality Assurance Measures

Quality assurance is a critical aspect of clinical trials. Back translations, which involve translating the translated text back into the source language, can be valuable for maintaining accuracy. You should ask the service provider if they offer this option or whether they consider it standard practice. This additional step aids in identifying any discrepancies and maintaining translation accuracy, especially with complex medical content.

5. Timeliness and Responsiveness

Timeliness is critical in clinical trials, impacting both health outcomes and financial considerations. Many clinical trials, approximately 80%, face challenges in meeting initial enrollment targets and timelines, resulting in significant financial losses for drug development companies. Therefore, it’s important to ask about the timing associated with the translation process:

It’s important to inquire about the timeframes associated with the translation process: 

• How long does it take to receive a quote? A timely response indicates an organized service provider.
• What is the translation delivery timeline? Ensure that the translation delivery timeline fits your project’s deadlines.
• Are rush options available? In cases where urgent translations are needed, having expedited options is important for keeping the trial on schedule.

Remember, people’s lives are at stake, so time is of the essence.

Conclusion

In conclusion, choosing the right translation service provider for your clinical trial documents is critical. These documents are not just words—they represent critical information that impacts patient safety, regulatory compliance, and the success of medical interventions. As you embark on this crucial selection process, remember the five key considerations outlined in this article. 

At DTS Language Services, clinical trial translations are our specialty. We offer an industry-leading experience with certified translations, guaranteed turnaround times, and responsive project management. We understand the importance of clinical trials for obtaining premarket approval (PMA), especially for Class III and occasionally Class II pharmaceuticals and medical devices, which undergo extensive review processes.

With decades of experience, we have worked closely with clinical research organizations (CROs) and pharmaceutical and medical device companies. We are familiar with the complexities of preparing for and conducting clinical trials. Our expertise lies in translating trial documentation for Institutional Review Board (IRB) and Food and Drug Administration (FDA) approval, as well as for international agencies like the China Food and Drug Administration (CFDA).