Clinical trial design in neonatal pharmacology: effect of center differences, with lessons from the Pediatric Oncology Cooperative Research experience.

Journal Article (Journal Article)

Survival for premature neonates has improved dramatically over the past 20 years; however, there has been minimal improvement in prematurity-associated morbidities. Morbidity rates and assessment of outcomes vary across neonatology intensive care units (NICUs). Here, we address the reasons underlying these differences, note the impact that this center variation has on trial design and interpretation, and highlight the success of the efforts in pediatric oncology to develop standards of care through the conduct of multicenter clinical trials.

Full Text

Duke Authors

Cited Authors

  • Moran, C; Smith, PB; Cohen-Wolkowiez, M; Benjamin, DK

Published Date

  • December 2009

Published In

Volume / Issue

  • 86 / 6

Start / End Page

  • 589 - 591

PubMed ID

  • 19915602

Pubmed Central ID

  • PMC2782890

Electronic International Standard Serial Number (EISSN)

  • 1532-6535

Digital Object Identifier (DOI)

  • 10.1038/clpt.2009.175


  • eng

Conference Location

  • United States