Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation.

ABSTRACT:

Background/aims

The Pediatric Research Equity Act and Best Pharmaceuticals for Children Act are intended to promote the conduct of clinical trials that generate pediatric-specific evidence about drug safety and efficacy. This study assesses the quality of evidence generated through Pediatric Research Equity Act-mandated and Best Pharmaceuticals for Children Act-incentivized clinical trials of hematology/oncology drugs and characterizes subsequent changes in pediatric drug utilization rates.

Methods

Trial characteristics (blinding, randomization, and comparator group) were determined for clinical trials that supported pediatric label changes. Using data from OptumLabs^® Data Warehouse, a de-identified administrative claims database, we calculated pediatric utilizati

SUBMITTER: Benning TJ 

PROVIDER: S-EPMC10119689 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature