Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.

ABSTRACT:

Importance

The increasing prevalence of pediatric chronic disease has resulted in increased exposure to long-term drug therapy in children. The duration of recently completed drug trials that support approval for drug therapy in children with chronic diseases has not been systematically evaluated. Such information is a vital first step in forming safety pharmacovigilance strategies for drugs used for long-term therapy in children.

Objective

To characterize the duration of clinical trials submitted to the US Food and Drug Administration (FDA) for pediatric drug approvals, with a focus on drugs used for long-term therapy.

Design and setting

A review was performed of all safety and efficacy clinical trials conducted under the Best Pharmaceuticals for Children Act or the

SUBMITTER: Zimmerman KO 

PROVIDER: S-EPMC6526087 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature