When are clinical trial translations required?


clinical trial translation

30 Oct When are clinical trial translations required?

Clinical trials are the most important documents in medicine. You probably know that clinical trials are research studies on people aimed at evaluating a medical, surgical, or behavioral intervention. Clinical trials are the main way researchers have of finding out whether a new treatment, such as a new drug, diet or medical device, is safe and effective for people, so a clincial trial translation is important when it comes to sharing new advances in medicine.

Without borders

Nowadays it is common to need a clinical trial translation. That’s because more and more clinical trials are run outside their country of origin.  Recent studies reveal that most trials are carried out away from the country in which the researchers live. This shift to holding foreign trials means that professional translation services are necessary to accurately implement them and explain their outcomes.

In fact, running trials in foreign locations may result in them involving different languages and cultures and this can lead to confusion. Most medical translators have medical knowledge, so can also help interpret clinical trials.

Clinical trials are often used to identify whether a new treatment is more effective and/or has fewer harmful side effects than the normal treatment. That is why hospitals, medical companies and pharmaceutical companies require the services of professional medical translation agencies such as Okomeds.

Translation regulations

The translation of clinical trials is regulated in Spain, the United States and other countries. The law says that any documentation used for patients or investigators must be in the local language. In Spain, for example, an authorisation is required from the Spanish Agency of Medicines and Medical Devices, which is issued after approval is obtained from an accredited clinical-research ethics committee in accordance with the guidelines for performing trials in Spain published by the Ministry of Health and Consumer Affairs.

One of the documents in the file that must accompany applications for permission to perform a trial is the protocol. The research protocol for a clinical trial is a document that specifies in writing the aims, methodology, type of statistical analysis, administrative details, and organisation of the clinical trial before patient-recruitment begins and for that reason it is important to have it translated into the local language.


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