The protocol is a key document for every clinical trial. It is fundamental to the entire research project, defines the objective and describes the design of the study as well as details of the applied methodology and methods of statistical analysis. It provides guidance for all persons and entities involved in the project, thus supporting communication between them. The study protocol is a formal document which is very unique and complex. It should be written in a precise and clear language to avoid ambiguity. Protocols contain both medical terminology as well as expressions from the field of statistics and laboratory practice, which is why they stand out against other clinical research project documents. Currently, thanks to the latest IT solutions used in clinical trials, responsible teams are able to monitor information recorded in electronic patient databases on an ongoing basis, draw conclusions from them during the study and properly adjust the study design to the needs of patients. This results in an increased number of amendments to the protocol, and each of them has to be translated and submitted to regulatory agencies and ethics committees.
The most important value observed during each clinical trial is obviously patient safety and health. Taking into account that each study protocol includes guidelines for conducting the entire study, the key to success is providing the protocol in a language version that will enable its recipients to fully understand the content. Unfortunately, the original version of the clinical trial protocol will usually not be fit for this purpose, because protocols are usually drafted in English. Investigators must be able to thoroughly familiarize themselves with the protocol in order to properly treat patients, but also to have a full understanding of the inclusion and exclusion criteria which they will need to strictly follow while recruiting study subjects. Even if an investigator has advanced foreign language skills, they need to have easily available, clear and precise instructions from the protocol always at their disposal. Although an investigator may perfectly understand the protocol written in English, it may be challenging for him/her to answer patients’ questions because this would require translating parts of the document into another language. Speaking of that, there is a big difference between reading written materials to gain a general understanding of a topic and being able to actually discuss the content learned in a foreign language. Therefore, the study protocol translated into the local language by a qualified translator is indispensable for investigators to effectively work with their patients. After all, investigators cannot accurately translate hundreds of pages themselves. We all know that time is at a premium for physicians. Often it is the matter of life and death.
In order to overcome linguistic and cultural barriers in international clinical trials, globalisation techniques should be discussed at the early stages of strategic planning. Although nowadays technology plays a significant role in translating clinical trial-related documents, translators specialising in medical translations, with relevant expertise in biomedicine as well as international procedures and regulations, are still of great importance. These specialists are able to take cultural differences into account which, if not clearly understood, may jeopardize the clinical trial – consider, for example, differences in the attitude of patients and their families to mental disorders or sexuality. Many studies have shown that culture and the language spoken by the patients significantly impact their perception of the disease and its symptoms. In order to improve the effectiveness of their work, professional translators independently create translation memories and glossaries or use such resources provided by their organisation. These resources are a treasure house of preferred terminology and expressions commonly used in a given language. For example, in South Africa, words such as ‘randomization’ or ‘placebo’, which do not have local language equivalents, may be extremely problematic to render. However, a professional will be able to easily overcome this obstacle.
In the process of preparing documentation for clinical trials, emphasis is mostly placed on translation of various materials for patients, which, of course, is a correct approach. However, given the above intricacies, a correctly translated study protocol provided to investigators may have a major impact on how the study is presented to potential patients and thus also on their recruitment. If an investigator does not accurately understand the protocol, a large number of protocol deviations are reported. This, in turn, may cause many problems during the process of registering a new drug, despite its proven efficacy and benefits it may bring to patients. KONTEKST makes every effort to help investigators understand information about clinical studies which you conduct. In this way we help them manage patients effectively throughout the study.