Clinical trial translation is an essential part of the process when new drugs are introduced into the market. Find out the best practices and challenges that you must be aware of during this translation process.
There are several moving parts involved in translating clinical trials. Getting the translation done right cannot be overstated, especially when it involves bringing a new product into the market. Whether you are translating in-house or outsourcing, it is important to watch out for the common pitfalls and the best practices to ensure quality control.
There is a growing demand for translating clinical trials as more emerging nations are involved with conducting clinical trials of their own or the manufacture of new drugs. Clinical research is responsible for significantly reducing the cost of introducing new drugs into the market. However, poor translation can add to the cost.
When you choose the wrong translation services provider, it could compromise the integrity of your clinical research and study. It is important to safeguard this entire process by imposing regulated standards not just in conducting the clinical trial, but also during translation.
A reliable medical translation service can ensure that the parameters of the clinical study are being upheld and that it is effectively communicated in various languages.
Regulation of Clinical Trial Translations
There are a variety of regulations involved with translating clinical trials. It is important to consider this before you work with a medical translation company. This not only ensures compliance, but also the quality of the translation that you can get.
There are a number of regulating bodies that govern the quality of clinical trials and research protocols. Some of them include the European Union, the World Health Organisation (WHO), FDA, the International Conference on Harmonisation of Technical Requirements, and any local regulating bodies. Depending on where the clinical research and trial is being conducted, you need to check with local rules and regulations.
These entities are responsible for overseeing the clinical trials and the medical translations to ensure that they meet ethical standards. Various entities will also observe differing rules when it comes to the medical translation. In addition to that, quality translation to the foreign language is an ethical imperative. No matter the type of language that the patient speaks, it is important that they are properly informed and can provide consent when they participate in a clinical trial. This is where accurate, complete, and honest translation comes into the picture. Moreover, the medical translation must be presented in a way that would be easy to understand even for non-medical people. Even a small confusion with the translation can have a significant impact on the patient or clinical trial participants.
The regulation of translating clinical trials does not end there. It also applies in the process of evaluating data and results. Translating the data into a foreign language will make it easy to access for scientists from all over the world, not just among English-speaking nations.
Medical translation presents several challenges. Medical translators must be fully aware of the regulations that govern this process of translation. To help you come up with an actionable plan to overcome these hurdles, take time to learn about these challenges and their potential impact on the translation of clinical trial documents.
Identifying Target Audience
Medical content typically has two types of audience: medical professionals and patients (or lay-person). There is a huge gap in the knowledge on medical texts and terminologies between these two types of audience.
Before you carry out the medical translation, it is important to identify specifically who you are translating for. This will inform the medical translator about the appropriate language and terminology to use based on the intended audience.
Citing Medical Drugs
The translation of the medical drug names is another factor that can complicate the process of medical translation. The most basic aspect that you need to consider here is when naming the brand name versus the chemical name. This one could be easily confused with a medical translator who isn’t an expert in the field.
When translating, it is important that both the brand name and the drug name must be mentioned in the medical document. This will inform the audience about the type of drugs they consume (when written for patients).
Overcoming Ambiguity of the Language
There are several medical jargons that are used by medical professionals. It is important that you are aware of these jargons when translating clinical trial documents. Not everyone (especially patients with no medical background) might be able to discern what these jargons mean.
One example is the use of medical eponyms, or those diseases or conditions that are named after a person. This type of name might not apply to all countries or people from various backgrounds. For example, Lou Gehrig’s disease is a term used among English speakers but this disease might go by a different name in another country. When translating clinical trial documents, always be sensitive about the ambiguity of medical terms and use the one that is most appropriate for the translated language.
Best Practices of Clinical Trial Translation
Poor quality medical translation can put your credibility at risk, as well as the health and safety of your patients. It’s not enough that you are aware of the challenges that are present when translating medical documents. You need to also take proactive measures to follow the best practices that ensure the quality of results in order for the medical document to serve its purpose.
Set Translation Standards and Be Consistent
Translating clinical trials demands proficiency in language skills and medical knowledge. It is difficult to find both but they can be achieved when you hire experts, such as medical translators who specialise in handling these types of documents.
Another way to get around this issue is to set a standard. This will ensure that you can follow protocols while maintaining the quality of your medical translation. Look for a translation service provider that is able to follow your desired workflow for this particular project while understanding the risks involved in delivering their work. This ensures that you are on the same page as far as meeting regulatory guidelines and standards are concerned.
If you do this, you can avoid risks and liabilities associated with the information contained in the translated document/s.
First and foremost, it is important to emphasise the value of human translation, especially in the medical field. The human touch will provide relevance and accuracy to the data being translated. Human translators understand who the target audience is for the translated document and that can factor into how the translation is done.
However, it does not hurt to employ supporting tools that can mitigate human error. There are several tools such as the translation memory that will help your translated documents stay accurate and consistent. This tool must be set up prior to the start of the project.
The job of the memory tool is to analyse the terminology and jargon used for the medical translation. The tool will verify the use of these terms and jargons throughout the document for accuracy and the relevance of their use. Think of this as a support tool rather than a replacement for human medical translators.
Make Translations Compliant
Compliance is number one on organisations’ minds when dealing with translated clinical trials and other medical documents. It is the process that you put in place that ensures you abide by these compliance rules.
If possible, localise your translation by choosing a translator that is well-informed about the local regulatory guidelines on medical devices and drugs. This is important so that you can implement the necessary context for translating clinical trials
Get the Translation Team Involved Early On
The moment you decide to work with a medical translation company, you need to get them involved from the get-go. They need to fully understand the extent and scope of the clinical trial as it can factor into the relevant documents. This will ensure a better quality result than if they were to step in at the end of the process and translate the documents without fully understanding what and who the documents are for.
Consider the medical translators as part of this whole process, rather than a third-party. This is also one of the best ways to avoid any regulatory issues that could arise later on.
Look for ISO Certified Translation Services
ISO Certification is one way that you can gauge the quality and proficiency of a medical translation provider. The process of obtaining an ISO certificate is time-consuming and tedious. While it is voluntary, it is a measure of a company’s commitment to ensure quality and to live up to the international standards when it comes to translation services.
Consider this as one of the primary factors when choosing the right medical translation agency to hire.