Translation of clinical trials

Why translate medical documentation?

Our clients entrust us with the translation of all types of specialised medical documentation: from translating clinical trial protocols or ICDs (Informed Consents) to RDCs, Patient and Medical Journals, IDUs or Instructions for Use, abstracts of papers, specialised web environments, etc.

Clinical trial translation involves in-depth medical and scientific knowledge. A clinical trial protocol translator must master both the standardized language accepted by the major International Healthcare Organizations and Ethics Committees and the specialized medical language used in the study or trial protocol. In addition, the translation must be written in perfect language, without errors, and accurately, both in content and form.

If you want to guarantee that the translations of your protocols are perfect, write to us and we will propose the best solution with guarantees.

Our procedures

If we are commissioned to translate the protocol of a clinical trial, we cannot approach the task as if it were a medical text, extremely specialized, just like that. In Spain, biomedical research through clinical trials is subject to the legal system so that, when a pharmaceutical laboratory wishes to conduct a clinical trial in our country, it must first obtain the necessary authorisation to do so. The approval of a clinical trial requires the submission of the relevant application form, accompanied by a series of mandatory documents, including the protocol.

Before proceeding further, the terms “clinical trial” and “clinical trial protocol” referred to in the previous paragraph should be briefly defined and explained.

A “clinical trial” is, in its broadest sense, “any research conducted on human beings. Once a new active ingredient has been sufficiently evaluated in in vitro models and experimental (animal) models, clinical research in humans begins: the clinical trial.

The clinical trial was created to provide a scientific response to the ethical need to guarantee the efficacy and safety of the treatment received by patients. It offers a controlled, objective and reproducible method for measuring the effects of a treatment on health and, therefore, makes it possible to objectively determine its usefulness. The clinical trial is still an “experiment” involving human beings and this experimental character with people gives it an ethical significance that requires extreme care, taking into account the possible impact of its results, as they can determine the treatment that will receive countless patients.

Having said that, it is essential that the clinical trial has three dimensions: the methodological or scientific dimension, the ethical dimension and the normative or regulatory dimension, since it is not only necessary to guarantee the reliability of the data but also to protect the integrity and the rights of the patients. To this end, there is a Good Clinical Practice (GCP) guide, an international standard of ethical and scientific quality applicable to the design, conduct, registration and communication of clinical trials involving human subjects. “Compliance with this standard provides a public guarantee of the protection of the rights, safety and well-being of trial subjects in accordance with the principles of the Declaration of Helsinki, as well as guarantees the credibility of clinical trial data.

The “clinical trial protocol” can be briefly defined as “the set of relevant instructions and data that investigators must follow and know in order to conduct a clinical trial”. This is a document describing the objectives, design, methodology, statistical considerations and organisation of a trial. The structure and content of the protocol must comply with the provisions of Royal Decree 223/2004, of 6 February, which regulates clinical trials with medicines carried out in Spain.

Once these two concepts have been clarified, let us approach the subject we are dealing with in a telegraphic manner – not to go into too much detail – clinical trial translation. First of all, as translators, we must consider issues such as the following:

It is a document addressed to ethics committees, regulatory authorities, researchers and monitors, and the research team. It therefore uses scientific language: formal, extremely specialised and of great technical complexity; the wording must be precise, clear and concise, with no room for ambiguity.

Apart from the terminology that can be considered proper to clinical trials -non-inferiority study, double-blind, inclusion criteria or primary endpoint-, it can include terminology proper to multiple sciences and fields of knowledge: medicine -nasopharyngitis, insomnia or pneumonia-, chemistry (laboratory) -aspartate aminotransferase (AST), chloride or total bilirrubin-, statistics -Kaplan-Meier plot, hazard ratio or Cox’s regression model-, etc.

In the Spanish translation of a clinical trial protocol written in English, we will undoubtedly have to resolve all those issues raised by virtually any translation from English to Spanish (medical and non-medical), such as the abuse of passive voice, capital letters and possessive. However, we must also consider other issues specific to medical translation, such as the combined use of medical technical terminology and less technical terminology or the unnecessary repetition and even exhaustion of certain words in the English text.

To finish..

We could not conclude without mentioning the importance of the MEDDra dictionary (Medical Dictionary for Regulatory Activities), the use of which is required by all clients who commission clinical trial translations. This includes the terminology developed by the International Conference for the Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use (ICH), whose purpose is to have a standardized medical terminology in order to facilitate the exchange of regulatory information on medical products for human use in an international environment.