Pediatric clinical research, especially in rare diseases, faces persistent challenges including the identification and recruitment of eligible patients, assessing protocol feasibility, and ensuring efficient trial execution. These issues are compounded by small, age-stratified populations and fragmented clinical data. Real-world data (RWD), especially when drawn from electronic health records (EHRs), present an opportunity to support innovative trial designs, such as real-world comparator arms and postmarketing surveillance. However, realizing this potential depends on the routine availability of structured, reusable clinical data.
Read more here!
Related posts:
Paediatric pharmacovigilance
Paediatric drug development & use could benefit from OMICs
New Publication: Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration
GLOPAD Paediatric Use Case: Important Considerations in Assessing the Population Representativeness of Paediatric Clinical Trials