Ensuring that children and their caregivers fully understand the details of a pediatric clinical trial is essential for the success of the study. However, there are many challenges, including language barriers and a lack of understanding about the purpose and details of the study. In this article, I focus on the types of materials that should be developed and translated, and how medical translation helps to effectively engage pediatric patients in clinical trials.
Developing pediatric clinical trials is crucial for advancing our understanding of diseases and treatments and improving the health outcomes for children worldwide.
Medical translation can be very helpful in engaging pediatric patients in clinical trials because it allows for effective communication between the research team and the child and their family.
Children and their families feel more comfortable and willing to participate in a clinical trial when they can understand the details of the trial and the potential risks and benefits of their participation.
Additionally, correctly translating all relevant information can help ensure that the child's medical care is appropriately coordinated and that any treatment or follow-up care is provided in a way that is consistent with the child's needs and preferences.
Accurate and reliable translations of informed consent and assent forms, information sheets, and other important materials will enable children and their families to understand the details of the study and make informed decisions. Ultimately, that will improve the chances of pediatric patient recruitment and retention success and the health outcomes for children worldwide.
What types of materials should you develop and translate?
Several materials should be developed and translated for children and their caregivers to effectively engage them in clinical trials. Some examples include:
Consent and assent forms and information sheets: These documents outline the details of the clinical trial, including the purpose of the study, the procedures involved, the potential risks and benefits of participation, and the participant’s rights. They should be written in language that is easy to understand and cover all of the key points of the study.
Treatment instructions: Children and their caregivers should be provided with clear and concise instructions for any treatment or procedure related to the clinical trial.
Patient education materials: Educational materials, such as brochures, help explain the purpose of the clinical trial and how it may benefit the child and others.
Contact information: Children and their caregivers should be given contact information for the medical team, including the names and roles of site staff, in case they have any questions or concerns.
In addition to written materials, multimedia materials can be powerful tools for engaging children and their caregivers in clinical trials.
They can be used to introduce the clinical trial and its purpose, explain the details of the procedures involved, show the child what to expect during the study, provide instructions for treatment or follow-up care, and even help children and their caregivers track their progress. For example:
Videos: Videos can be a very effective way to explain complex information in an engaging and visual way.
Illustrations: Illustrations and other visual aids can help to make complex information more accessible and easier to understand.
Interactive tools: Interactive tools, such as games or apps, can be a fun and engaging way to teach children about clinical trials and their participation.
It is vital to ensure that all materials are appropriate for the child's age and level of understanding and that this content is translated accurately.
To sum up, here’s what you should do:
Identify the language needs of pediatric patients and their families. It is essential to determine the languages spoken by the children and their families to identify the need for medical translation services.
Develop, translate and localize all written materials, visual aids and other forms of non-verbal communication to help convey information to children and their families.
Use the services of a qualified medical translator. It is essential to work with a professional medical translator with the necessary skills and expertise to translate complex medical terminology and concepts accurately using a language that is appropriate for the intended audience.
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.
