Different language versions of study-related materials rate among the basic tools used to increase patient diversity in clinical trials. They are of particular importance because language barriers may prevent information about a conducted study from reaching potential patients. If study-related content made available to the public takes into account the nature and nuances of the target language, it effectively raises awareness of clinical trials among ethnic minorities. Languages and translation undoubtedly play a key role in the case of patient diaries or patient-reported outcomes (PROs), whose significance in clinical trials is constantly increasing.

PRO is defined by the U.S. Food and Drug Administration (FDA) as ‘any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else’. That said, the term PRO is treated as an umbrella term which not only encompasses patient-reported disease signs and symptoms, side effects of treatment (such as fatigue and pain), information on social, emotional functioning and sex life, but also comprehensive assessment tools, such as health-related quality of life questionnaires (HRQoL). These tools provide unique information about the impact of disease and treatment on a patient from his/her own perspective. PROs which are endpoints in the study are assessed using verified questionnaires to ensure standardization and identical approach to each study subject, which cannot be guaranteed by asking open-ended verbal questions (source: LINK).

Obtaining properly translated PRO tools to be used in many countries is extremely difficult and complex, and it is not enough to just translate them word for word. In order to accurately and faithfully express the meaning of the source document, cultural differences should also be taken into account.

In its guidelines the European Medicines Agency (EMA) emphasises (LINK) the need for equivalence of all language versions as a key issue in the assessment of questionnaires, while the FDA included a number of specific recommendations in its guidelines (LINK). FDA recommends that sponsors of clinical studies provide evidence confirming equivalence of all versions of the questionnaires used in the study. In order to meet regulatory agencies’ requirements, translation of PRO measures should be a multistage process and it typically begins with the translation of the original document into the target language by two independent translators. Afterwards, both translations should be compared and one final version should be created on this basis. The next step is translating the final version back into the source language. At a later stage, the obtained document in the source language should be analysed, among others by the creator the original questionnaire or tool. Then the translation is tested by a group of patients speaking the target language and living in the country where the study is or will be conducted. The result of this test is evaluated by experts, and then the translated version of the questionnaire is finalised. The whole process is very complex, but it allows to obtain outcome assessment questionnaires that take into account all factors relevant to the patients who will complete them (e.g. cultural or environmental factors, but also the patients’ level of education) (source: LINK).

Currently, a significant portion of the PRO instruments used in clinical trials is created in the form of electronic patient diaries. This creates a need for additional review of final screenshots to make sure that translated content has been accurately transferred to the electronic platform. In order to avoid unauthorized changes, the review process should be carried out by the same team that worked on the translation. Effective cooperation between the provider of translation services and the provider of electronic diaries is crucial in order for the study to start at a specified time. It is recommended that the same translation provider is engaged in the preparation of translations of all related PRO instruments. This will ensure consistency of terminology and the same methodology used in translation into all relevant languages. An experienced translation provider has knowledge necessary to deal with translation nuances, which will certainly have a positive impact on harmonisation and faster delivery of PRO instrument translations (source: LINK).

KONTEKST works with a large group of experienced translators with appropriate expertise, thanks to which we are able to provide you with high-quality translations of patient questionnaires. We are able to meet the strict requirements of regulatory agencies and ensure that your studies begin within designated timelines.