Clinical trials are carried out for new drugs, medical devices, or more progressive forms of treatment and quite often the best researchers are located abroad. In the past years, China, India, and Russia have established themselves as some of the leading countries in the sector. As the results are produced in their native language, the translation of the clinical trials becomes necessary in order to reach a broader audience and allow more researches to make use of the results.
While the translation of clinical trials is a translation of documents in its essence, it bears the specifications of technical translation and medical translation as well. So, it is necessary to be aware of its necessity and the issues an improper translation service can cause.
To get the best translation for your clinical trials you should know the best practices in the industry and select the language service provider (LSP) that is capable of following them. Below, you can find five of the best translation practices for clinical trials that will guarantee a high quality of the provided service.
Evaluating the necessity of translation for clinical trials
As a sponsor of the clinical trial, it is up to you to decide where to have the trial completed and if the results should be translated
If you choose to outsource the clinical trial process to a different country, you will definitely need the results translated into your native language so that you can present them to the necessary board and await approval of the drug, treatment, or device. The translation
If you have conducted the medical trials in your own country and the results are published in English, for example, you may also want to translate them in other languages in order to provide researchers with the option to evaluate them easier.
Establishing and maintaining a clinical trials-related terminology library
Once you have decided on having your clinical trial results translated, you shall work towards establishing a smooth translation process. One of the responsible steps to make is to compile a library of clinical trials-related terminology and add references to other research paperwork or documentation that will facilitate the actual translation.
You could use previous content that was already certified by the relevant body as a background. It is necessary to maintain the library and provide it to the translation company you have chosen for the clinical trials in order to ensure high quality and consistency of the translation.
Being familiar with the regulations governing the translation of clinical trials
The translation of clinical research is subject to specific regulations and requirements issued by the various bodies regulating the industry. Some of the notable institutions to take into account are the FDA, local governments, the World Health Organization, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the European Union and its new regulations on medical devices the European Union Medical Device Regulations (MDR) – Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It is necessary to comply with the rules these bodies have in relation to the translation of clinical trials and all the documentation related to them.
In addition to all of these requirements, it is also necessary to give patients participating in the trials the right to have informed consent regardless of the language they speak. The informed consent forms should be properly translated in the language of the clinical research participants so that they are
Choosing the right translation company for clinical trials
All of the documentation related to clinical trials should be consistent and bear the same information regardless of the language it is translated into. So, it is necessary to select the right vendor. While a freelance translator might provide you with a better price quote, an established agency with experience in the field will provide you with high-quality service in all aspects. You can rely on their expertise and experience and draw on their knowledge in the field for every step of the translation process.
An LSP that has dealt with the translation of clinical trials before is the best choice you can make since the professionals within the company are already familiar with the path a translation process of this kind has to follow in order to achieve its ultimate goal. In addition to that, an agency will be able to provide a translation of the same quality in several languages which is another major point to consider when selecting your translation partner.
Being aware of translation issues related to clinical trials
The results of clinical research are quite specific and translation mistakes can be detrimental. If the quality of the translation does not correspond to the quality of the original text it may lead to improper conclusions of the clinical trial results.
In some cases, researchers prefer to work with the original text in order to avoid possible omissions or misleading content in the translated version. This, however, limits the access to the clinical results only to those researchers who speak the language of the original text sufficiently well to be able freely to interpret its conclusions.
Bearing in mind the necessity of translation of clinical trials and the possible repercussions of an improperly translated text is part of the good practices both client and vendor should follow. As the texts of such documents are often complicated and dense with specific terminology, it is necessary to work with linguists who are subject-matter experts in the field and make no compromise with the quality of the translation.
Here at ICD Translation, we have significant experience in working with the medical industry and we are ready to support your translation for clinical research in any language you need.