Communicating with children and their families: Engaging patient expert feedback and new media approaches to improve paediatric informed consent forms and lay summaries
Communicating clinical trial information to the public is inherently challenging, given the complexity of medical terminology, procedures, and risks. This challenge is magnified when explaining clinical trials to children, who require clear, age-appropriate information to understand their participation. It is…
Compiling with the Regulatory Requirement of the patient engagement process with pediatrics and their caregivers
There is a growing expectation from regulatory agencies for sponsors to provide robust patient experience data that demonstrate the impact their drugs may have on the quality of life for paediatric patients and their caregivers. This involves meaningful involvement of…
Mastering the ICF and Assent Best Practises
Effective communication with children and parents involved in clinical trials is crucial for fostering trust and ensuring informed participation. Ensuring that children and their parents fully understand the information provided during clinical trial participation is both a legal and ethical…
Paediatric patient facing documents: involving children and young people
The involvement of children and young people in the drug development process is not common practice. Regulatory agencies, such as the European Medicines Agency (EMA), encourage patient involvement in study protocol design, and there is evidence of the benefits of…