Let's get started by briefly defining what clinical trials basically are.
The World Health Organization (WHO) describes the clinical trial as a research study that analyzes health-related tests and treatments to see how they affect human health. These studies involve the assistance of human volunteers who participate in it. Whereas health research institutes and ethics committees supervise them.
Now the goals of different clinical trials could be different. For instance, one clinical research might be looking for ways to identify, diagnose, or examine the progression of a medical disease. While the other trial might be directed at exploring ways to stop a disease from developing.
Why is clinical trial translation important?
The translation of clinical trials falls under the category of medical translation. Talking about medical translation, it's vast and varied, covering all aspects of medicine, from discipline and industry to medicine as a service.
Areas like medical records translation services, clinical trial translation, and conversion of medical devices into different languages - all are different varieties of medical and healthcare translation.
Keeping this in mind, we can say that translation services for clinical trials are one of the many specialties within medical translation. They are important for three major reasons:
1. More participants
The translation of clinical trial documents allows you to reach a wider audience. Thus, increasing the number of possible volunteers.
2. Informed consent
By seeking clinical trial translation services, you fulfill your ethical obligation. You want to let potential volunteers make informed decisions. Plus, you enable them to safeguard their rights.
3. Global academic exchange
The translation of clinical trials is also important because it allows you to share your information with the global scientific community.
3 vital requirements for the translation of clinical trial protocols
The healthcare sector is quite complex as we all know. That said if you're dealing with the conversion of clinical trials into different languages, you must know these translations are very stringent and call for utmost accuracy and precision.
Before you hire a pharmaceutical translation agency for your project, it's crucial to understand the important translation requirements in this field.
Clear communication of clinical trials
Just like other medical texts, the clinical trials translation requires expertise on the subject matter. Plus, it demands that translators should be proficient in managing specific field-related terminology. For this reason, almost all pharmaceutical translation companies depend upon linguists having extensive medical backgrounds. Especially when it comes to clinical trials, research documents, and medical reports.
Expertise in the subject matter
Medical field knowledge isn't an option but a necessity to ensure the successful translation of international clinical trials. Clinical trial documents will contain various intricacies that only a field-specialist expert will be able to tackle them. Because a specialist translator has the required competence and the skills to exercise excellent attention to detail in this field.
Specific field terminology
It's the accurate and consistent use of field terminology that differentiates a good translation from the bad one. Therefore, achieving accuracy and consistency in your clinical trials translation is essential. This is often possible when you equip medical translators with the latest translation tools like terminology bases and glossaries.
Cultural considerations
Clear communication is necessary but subject-matter expertise and the right use of industry terminology aren't the only required to accomplish that. Rather, the translator should also take into account the contextual and cultural nuances of the intended audience.
But why does cultural context matter a lot in clinical trials or any other medical field? Note that medical and healthcare translation concerns patients, so literal translation won't do the job. With literal translation, you might have an accurate word-to-word version but it's sure to lack cultural subtleties.
When cultural subtleties are ignored in translation, your target audience is most likely to overlook critical factors about procedures. If it happens, the whole project can be jeopardized. Consequently, the patients' lives will be put in grave danger.
To overcome that, the translators need to have cultural awareness and maintain good readability of the final text. Before volunteers take part in the study, they fill out informed consent forms. Make sure to ask them questions in an appropriate manner. In some cultures, it's invasive to ask people personal questions. So, keep in mind that your volunteers don't feel reluctant to provide answers to your questions.
Regulatory perspective
The major thing that distinguishes medical translation from other translation types is normative compliance. If you're in the medical business, you'd know how national, international, local, and regional regulations restrict the medical field.
The reason is valid too. Clinical trial documents consist of sensitive data. If you don't govern them through standards and guidelines, you might put human lives at stake. The businesses can also have serious repercussions especially when entering a new country.
Your data will be only reliable when your clinical trial protocols comply with all the relevant regulatory bodies. These regulatory bodies can include The European Medicines Agency, The European Union, Food and Drug Administration, World Health Organization, and more.
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