The globalization of pediatric clinical trials.

Objective: To examine the characteristics of pediatric trials conducted under US legislation and to compare results with data from 2002 to 2007.

Methods: We reviewed all pediatric trials provided to the US Food and Drug Administration in submissions that were approved between September 28, 2007 and December 21, 2010. We extracted data for each trial including age range, therapeutic indication, design, duration, and patient and center enrollment by location.

Extrapolation of adult data and other data in pediatric drug-development programs.

Objectives: In 1994, the US Food and Drug Administration (FDA) proposed an approach, based on extrapolation of efficacy findings from adults to the pediatric population, to maximize the use of adult data and other data when designing pediatric drug-development programs. We examined the experience of the FDA in using extrapolation to evaluate how and when it was used and any changes in scientific assumptions over time.

Methods: We reviewed 370 pediatric studies submitted to the FDA between 1998 and 2008 in response to 159 written requests (166 products) issued under the Pediatric Exclusivity Provision.

The European Regulation on medicines for paediatric use.

The European Regulation on medicines for paediatric use entered into force on 26 January 2007. It marks a radical change in the European Union in terms of encouraging the development of medicines for paediatric age groups and improving the availability of information on the use of medicines in children. How will the new Paediatric Regulation achieve this? For the first time, companies will be required to study medicines in the paediatric population and develop age-appropriate formulations.