As a translation services provider specialising in clinical trials, this announcement by the EMA piqued our interest immediately. The goal of the Clinical Trial Regulation EU No. 536/2014, as mentioned on the website, is to ensure the “highest standards of safety for participants and increased transparency of trial information.”
The direction taken by this regulation emphasizes the serious impact of clinical trials on patients and pharmaceutical companies. With this in mind, we felt it was an excellent opportunity to discuss the importance of language translation in Clinical Trials.
Translation – Not Just an Afterthought
Strict guidelines, adherence to a code of ethics, sensitive documents subject to close scrutiny, the make or break of a pharma giant, and ultimately the fate of millions of patients – all this and more goes into the making of a clinical trial. Where does translation fit in though? With the myriads of steps that are involved in a clinical trial, does translation really play an important role?
Well, Yes. In connection with the Clinical Trial Regulation, a public consultation was conducted on "Risk proportionate approaches in clinical trials". An important aspect of this consultation was the “Summary of Clinical Trial Results for Laypersons." The document clearly outlines that “as a minimum, the summary is expected to be provided in the local language of each of the EU countries where the trial took place.” Further, it outlines that “communications written for the public should use simple everyday language to ensure ease of reading and understanding.”
Good comprehension of clinical trial documents has always been important in the medical industry. The Declaration of Helsinki developed by the World Medical Association (WMA), which is considered to be a cornerstone document on human research ethics, puts down these tenets:
“In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of … the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study … Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing.”
As this declaration brings out, it is crucial that the subjects of the clinical trial have a complete understanding of what is involved in the trial. “Understanding” here has many implications and especially so when it comes to translation. It means that the information presented to them must be accurately translated into their language, and use simple words and local expressions. As simple as this seems, it is anything but. Translating for clinical trials is a meticulous process that involves a great deal of thought, skill, proficiency and patience! These are the typical steps involved in a comprehensive translation process for Clinical Trials:
Create a terminology base from the translation memory.
Editing and Proofreading
Each of these steps must be carried out diligently. Translation that is accurate and easy to understand is crucial to the clinical trial and to the health and life of the patient. There are big stakes involved and pharmaceutical companies and CROs must exercise extreme caution in ensuring that the various legal and ethical considerations are met.
Having been in the industry for over a decade, Simpson Soft is dedicated to ensuring the accuracy of translation for Clinical Trials. Guided by this commitment, we have refined our processes to meet the stringent requirements of the ISO 17100:2015 standards and have hand-picked qualified resources in more than 300 languages. Patient Safety is extremely important to us.
We would be happy to answer your questions on translation for clinical trials. You can drop a comment here or contact us through the website.