Pediatric Clinical Trials: Designing the Right Trial for the Right Population

• Activity Number: 645
• Type: Contributed
• Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Government Statistics Section
• Author(s): Jennifer Clark*
• Companies: FDA
• Keywords: Clinical Trials ; Study Design

Abstract

In the face of changing pediatric recommendations from various medical committees and literature, it is important that the design and implementation of clinical trials for some of our most vulnerable populations capture treatment effects in a manner that is both efficient and ethical. With developmental and recruitment issues unique to the pediatric population, the design and implementation of clinical trials in this setting can often be some of the most challenging to apply. Additionally, advisory committees are systematically offering new recommendations for current treatment guidelines. Regulatory guidelines often require submission of pediatric trial designs years before they may actually be executed. In this respect, it is important that pediatric trial designs and chosen statistical methodology have a built in flexibility that can accommodate possible changes in future medical recommendations and pediatric populations.