Medical translation is currently one of the most technically demanding and sought-after forms of translation in the market. Translation has become an essential factor in enabling the dissemination of scientific knowledge and advancements in health care. Today, we will focus on a subtype of medical translation that transcends borders to unveil new treatments:
the translation of clinical trials or clinical trial protocols. Any type of clinical research requires translation services at some stage of its protocol. Let’s quickly review the processes that necessitate translation services.
Firstly, there are clinical trials which, at their core, involve any research conducted on humans once a new active ingredient has been sufficiently evaluated in in vitro and experimental models (animals). Once the initial phase of research concludes and human clinical investigation begins, we can refer to it as a clinical trial.
This is a complex task. In Spain, biomedical research through clinical trials is subject to legal regulations. When a pharmaceutical laboratory intends to conduct a clinical trial in our country, it must first obtain the necessary authorisation.
The approval of a clinical trial requires the submission of the corresponding application form, along with a set of mandatory documents, including the protocol.
A clinical trial is essentially a “study” involving human participants and its experimental nature with individuals imparts significant ethical considerations. Given the potential impact of its results, which can influence the treatment received by numerous patients, careful attention is essential.
The clinical trial protocol can be succinctly defined as “the comprehensive set of instructions and pertinent data that researchers must adhere to and understand in order to conduct a clinical trial”. It’s a document that details the objectives, design, methodology, statistical considerations and organisation of a trial.
Critical considerations for translating a clinical trial
Translating a clinical trial protocol requires in-depth specific medical and scientific expertise. It’s a document intended for healthcare professionals, researchers, pharmaceutical experts and other pertinent experts in the field. Unlike other documents that may be intended for patients, this one is exclusively for the scientific community.
A translator of clinical trial protocols must be proficient in both the standardised language accepted by the main international health organisations and ethics committees, as well as the specialised medical language used in the study or trial protocol.
Moreover, the translation must be articulated in flawless language, free from errors and with precision in both content and form. That’s why it’s crucial to work with certified professionals with experience in this field.
At Overseas Translations, our network comprises certified collaborators with extensive experience in the medical sector, including linguists with official qualifications in medicine or pharmacy. We also hold international ISO-9001 and ISO-17100 certifications for translation services, ensuring rigorous standards across all our internal processes and criteria for human resources selection.
What other documents need translation during clinical research?
The translation of a clinical trial is a task that may be divided into various stages depending on the type of trial and its development phase.
Numerous document types are involved in this process, each associated with a specific stage in the development of the treatment or medical device. During the preclinical phase, documents such as the clinical development plan or pharmaceutical dossier come into play.
During the clinical development phase of the treatment or medical device, we typically work with the Investigator Brochure (IB), clinical trial protocol, subject information and informed consent form, Investigational Medicinal Product Dossier (IMPD) and Summary of Product Characteristics (SmPC).
During this phase, translation needs may extend to documents like the data collection notebook or correspondence with the ethics committee. This might also involve translating supplementary materials, such as the curriculum vitae of the principal investigator and his or her partners.
After obtaining marketing authorisation, the trial enters the marketing phase of the pharmaceutical product or medical device. This stage involves documents aimed at patients and for commercial purposes, as well as all documentation related to the pharmacovigilance of the treatment.
This phase involves working with documents such as periodic safety reports and risk management plans and ultimately, the investigator’s final report that compiles all information related to the trial, including results and conclusions.
An example of a document subject to translation due to legal requirements is the informed consent form.
Translation of informed consent forms
Translating an informed consent form is another task undertaken by medical translators. In this document, a doctor informs a patient about their illness, explains medical procedures and seeks the patient’s consent.
The translator of informed consent forms needs to employ a register comprehensible to non-expert patients. It’s therefore crucial to fully understand the source text’s subject matter to convey the information in simple language accessible to wide audiences.
Translating informed consent forms entails rendering technical language into another language, ensuring clear comprehension by individuals not versed in the subject, all while upholding the integrity of the original text.
For this type of translation, the translator must consider three fundamental pillars:
- Medical terminology;
- Colloquial language;
- The standards accepted by the international medical community.
Overseas Translations’ medical translation expertise
At Overseas Translations, we work with translators not only specialised and trained in medical translation, but also professionals capable of addressing all the issues posed by practically any translation in any language combination, be it medical and non-medical.
These are professionals who also consider other issues inherent to medical translation, such as the combined use of technical medical terminology and less technical terms, as well as avoiding unnecessary repetition of certain words in the original English text.
For us, specialised translation for clinical trials is pivotal for various reasons:
Translation helps to ensure trial participation
A precise, clear and comprehensive translation of a clinical trial can guarantee that participants feel well-informed and at ease regarding the trial’s objectives, procedures and terminology.
Doubts, confusion and misinterpretation inevitably result in lower participation and higher dropout rates.
Greater consistency fosters more confidence and increased reliability
The translation of clinical trials should maintain a high level of consistency to ensure coherence in trial results. A specialised pharmaceutical translation provider will help to balance essential technical language and medical jargon with clear and accessible explanations.
This is a crucial factor in combining scientific data with consent forms and the information conveyed to the patient, where a more straightforward language is deemed more suitable.
The translation must comply with specific regulations
In some countries, such as the United States, it’s mandatory to translate clinical trial documentation into local languages for all participants. In others, like Spain, it’s not.
Despite the common belief that most researchers have an advanced proficiency in English, many regulatory bodies and ethics committees stress the significance of having documentation available in local languages—a requirement that can prevent a host of issues during the trial’s development.
The importance of localisation in the medical sector
Nowadays, specialised translation service providers play a crucial role in helping medical and pharmaceutical companies tailor their products and services to the variations across different markets and regions.
Localisation services encompass technical, cultural and content-related aspects, addressing variations in information, functionality and instrument design. Localisation becomes especially crucial when trials are conducted in countries with pronounced cultural differences.
An expert for a complex development process
Working with specialised and experienced translators throughout the entire process, from clinical research and review to submission to authorities, as well as production and marketing, can save time, money and streamline the process.
Get in touch with Overseas Translations when considering expert assistance for your clinical trial journey. We guarantee efficient resource allocation, no delays in bureaucratic processes and culturally and linguistically appropriate documentation from the outset.
