Cross-border access to clinical trials: participation of pediatric patients and language inclusion

The SJD Barcelona Children's Hospital Clinical Trials Unit operates under a one-stop-shop model, managing clinical studies with a special focus on rare diseases, centralizing all the needs of international patients (translations, accommodation, visas, etc.). The inclusion of international patients in pediatric clinical studies is feasible. Pediatric rare diseases require a small sample of patients, highly specialized sites, and flexibility to accommodate the necessary translations for patients. The final decision regarding the inclusion of international patients lies with the sponsor. Flexibility in including international patients directly impacts the study plan and execution, preventing time deviations.