International Collaborations

The Office of Pediatric Therapeutics is engaged in international collaborations to exchange scientific and ethical information pertaining to the conduct of pediatric trials.  The objective of these exchanges is to ensure that pediatric studies are conducted in a scientifically rigorous and ethical manner and that pediatric patients are not exposed to unnecessary (e.g. duplicative) trials.   

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Goals of the Exchange

• Avoid exposing children to unnecessary trials
• Enhance the science of pediatric product development
• This communication does not mean that pediatric development programs will have exactly the same pediatric protocols or ask the same questions or arrive at the same regulatory decisions.

Outline of the Process

• Monthly teleconference to discuss product-specific pediatric development and topics related to product classes
• Documents are exchanged through a secure link, Eudralink

Type of Information Exchanged

• Pediatric Investigational Plans (PIPs)
• Pediatric Committee (PDCO) Summary Reports
• Written Requests
• Waivers and deferrals
• Type of study: choice of comparator and efficacy endpoint
• Status of ongoing pediatric studies
• Results of pediatric studies
• Safety concerns, including clinical hold
• Plans for long-term safety monitoring

 

Triggers for Discussion

• Ethical or data integrity issues
• Safety concerns
• Different pediatric indications for development
• Pediatric study feasibility issues
• Pediatric studies completed (to avoid duplication)
• Outcome of pediatric studies, including negative studies
• Marketing approval differences

 

International Pediatric Statistics for the FDA and EMEA Information Exchanges

Product-specific statistics From August 2007 through March 2009:
Total: FDA provided information on 375 PIPs for 324 products
Discussed: 144 products