A clinical trial is a statistical survey carried out to test a new drug for its efficacy and safety. In the case of medical devices, this is referred to as a clinical investigation. The performance of a clinical trial is a main prerequisite for the approval of a new drug. This also applies to vaccines and drugs against SARS-CoV-2 which are currently being developed.
The planning and performance of a clinical trial are subject to strict legal requirements with regard to procedure, documentation, patient safety and data protection. The medical, legal and organizational complexity requires pharmaceutical companies, regulatory authorities, ethics committees and trial centers to maintain a close and constant exchange of information. Translations play an important role in this process and are therefore an integral part of the complex structure of an international clinical trial.
The aforementioned complexity of clinical trials requires the preparation of a whole range of documents: study plan, contracts with investigators and trial centers, patient information and consent forms, trial forms etc. In addition, this involves a lot of correspondence in the form of applications, notifications and approvals. Since the actual goal of the pharmaceutical company in question is ultimately to market the drug, the results of a clinical trial are published in scientific journals. In order to increase the statistical significance and develop more target markets with the drug, many clinical trials have an international focus and are conducted in several countries.
As a result, many of the documents and texts mentioned above generally have to be translated. And that's where things quickly get complicated – because this is not possible without a specialist translator. International clinical trials can only be carried out once all required documents have been translated. Some of these trials are conducted in multiple countries, often requiring the documents to be translated into more than just the most common European languages such as English, French or Russian.
The diversity of pharmaceutical documents and target groups mentioned above means that one document almost always contains information from different specialist areas. The translation of correspondence with international authorities or the relevant ethics committee requires not only medical know-how but also narrowly specialized knowledge of legal requirements. Patient information and consent forms for participants in the respective countries must precisely explain the content and procedure of the clinical trial, yet be easy to understand. The translation of a contract must not only correctly render the content, but also include the correct wording of any contractual clauses in the target language. And for a study plan or a scientific publication, translators need sound knowledge of statistics and scientific discourse. A precise and professional specialist translation of such documents can therefore only be done by experts who translate exclusively into their own native language.
While there are also documents, e.g. certain emails or communications, which are of a more general nature, the translation of highly specialized texts requires the translator to be thoroughly familiar with the subject matter. After all, who can distinguish a single-blind from a double-blind trial without prior knowledge? Or tell offhand what the specialized abbreviations DMC, CRF and CI mean and decide whether they need to be translated or not?
At AP Fachübersetzungen, we work with experienced translators who have mastered their native language at the highest level and, as experts in the fields of law, medicine, and pharmacy, are always up to the challenges of translating clinical trials.