Article Text
Abstract
Networking is key to overcoming the logistical, methodological and ethical problems related to the implementation of paediatric studies. The adoption of legislation to encourage paediatric clinical trials by the American and European regulatory agencies has opened a new era in the assessment of drug safety and efficacy in children. Two very large international trial networks – the Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO) – have played a critical role in the implementation of this legislation and have facilitated several successful controlled studies on the safety and the efficacy of new and old drugs in paediatric rheumatic diseases. The PRINTO and PRCSG networks can be seen as a model for international co-operation in other paediatric subspecialties.