Outsourcing trials is a good way to ensure diversity in trial participants. However, multinational trials face the challenge of overcoming linguistic and cultural differences, particularly when dealing with information aimed at patients. I examine four types of patient-facing materials that require extra attention during translation into the target country’s language.
Effective native language communication is an essential component in international clinical trials to adequately meet regulatory requirements in each country and address the linguistic and cultural differences among participants.
As the number of international trials increases, clinical success depends heavily on accurate translation to handle regulatory, linguistic, and cultural issues. Sponsors and Contract Research Organization (CROs) who adequately prepare for these will succeed in controlling trial costs and timelines, reducing risk, and improving patient retention and engagement.
The translation of clinical trial documents requires a high level of precision and accuracy. Choosing the appropriate language equivalents and considering every cultural factor requires proficiency in both the source and target languages, familiarity with local regulatory procedures, expertise in clinical research, and an understanding of both cultures.
Translating patient-facing materials (e.g., educational resources, marketing materials, trial documentation) in a way that resonates with local audiences will boost patient recruitment and engagement and help educate patients, caregivers, and the general public. Translators need to consider factors such as patients’ education level, medical knowledge, or awareness of their body.
There’s a real lack of diversity in clinical trials, and conducting clinical trials across multiple countries is an effective way to address this issue. Besides establishing a local presence and partnering with local investigators and sites, working with professional translators, particularly when translating patient-facing materials, should be a top priority for sponsors and CROs thus ensuring that any linguistic barriers are adequately addressed.
Here are the four main types of patient-facing materials that you need to ensure that are correctly translated:
1. (Pre-)Recruitment materials
Communication is key to explaining what trials involve and what participants can expect.
Trial advertising and information materials should be linguistically and culturally adapted to the target country's language, as well as aimed at a population with multiple education levels and cultural backgrounds.
Also, clinicians may be more inclined to discuss trial opportunities with patients when they have materials available in their (and their patients’) native language.
2. Informed Consent
Informed consent is one of the most critical documents, as clinical trials have adopted a more patient-centric approach with greater patient engagement. Furthermore, regulatory delays in clinical trials are often due to inconsistently or poorly translated informed consent forms.
Informed consent forms must follow a set of guidelines to ensure that patient rights are protected and that informed consent is obtained ethically.
3. Questionnaires and patient diaries
Clinical trials commonly require patients to fill out patient-reported outcomes (PROs) or quality of life (QoL) questionnaires and patient diaries.
Given that linguistic and cultural differences can affect patient reporting of disease symptoms and adverse events, these materials must go through a linguistic validation and cultural adaptation process.
4. Lay summaries
According to the Clinical Trials Regulation EU CTR 536/2014, lay summaries must be published in each country's language within one year after trial completion. Using easy-to-understand, non-technical language, lay summaries share the trial findings with study participants, families, caregivers, and the public, explaining why the trial took place, what researchers found, and how it changes the way a condition is treated.
To guarantee that the scientific integrity of the results is maintained, translating lay summaries requires the use of skilled linguists with clinical expertise who are capable of being not only accurate and complete but also brief and non-technical.
Ana Sofia is an English to Portuguese medical translator and writer working with Life Sciences companies, Contract Research Organizations, and Medical Communication agencies. She has experience translating and writing content for clinical trials, medical devices, regulatory submissions, education and marketing campaigns, and scientific publications.
