Translating Lay Summaries of Clinical Study Results
Lay Summaries Explained
Because ensuring transparency of clinical trials is a vital part of the process, The European Union Clinical Trials Regulation 536/2014 (EU CTR) set the requirement for sponsors of clinical trials to submit lay summaries of the results in local languages of all EU countries where the study was conducted. These easy-language summaries are meant to enable laypersons with limited scientific knowledge and low to average literacy skills to understand the study results. Therefore, a lay summary is a translation from the complex scientific language used to describe clinical research into a language that the general audience can understand.
This formal requirement, which was created as a result of the efforts of advocacy groups and research participants, is beyond doubt a step towards tightening the partnership between those conducting the clinical trial and the patient, and increasing the involvement of the latter. Until now, this provision has been included in European legislation, but it can be considered as an indication of the global direction in which the future of providing information on the conduct of clinical trials is headed. For that reason, it is also worth considering the issues related to the translation of such documents.
The process of describing the results in a manner that is accessible to all is undoubtedly a challenge, and so is to translate a lay summary into a foreign language. At KONTEKST, we are aware that keeping the original meaning while using a language understandable to the general public and ensuring cultural validity of the terminology used requires a very specific translation know-how. As an experienced life sciences translation provider, we offer comprehensive services designed to meet all the needs of Contract Research Organizations connected with these types of documents. In order to ensure maintenance of scientific integrity of the text, translations of lay summaries are performed by experienced subject-matter linguists. In addition to an expert forward translation, we offer back-translation and reconciliation services to ensure sensitive translation projects such as lay summaries are translated accurately in terms of content and style.
In conclusion, to make sure that the linguistic challenges of translating such documents are overcome, it is best to entrust them to experts such as our company. Clinical research translations are our main specialization and we support our global CRO clients with comprehensive services at all stages of the translation process. Order a lay summary translation at KONTEKST today.