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Clinical Trial Design in Neonatal Pharmacology: Effect of Center Differences, With Lessons From the Pediatric Oncology Cooperative Research Experience

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 underlyin...

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Published in:Clinical pharmacology and therapeutics 2009-12, Vol.86 (6), p.589-591
Main Authors: Moran, C, Smith, P B, Cohen‐Wolkowiez, M, Benjamin, D K
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Language:English
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description 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. Clinical Pharmacology & Therapeutics (2009) 86 6, 589–591. doi:10.1038/clpt.2009.175
doi_str_mv 10.1038/clpt.2009.175
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subjects Child, Preschool
Clinical Trials as Topic - standards
Cooperative Behavior
Evidence-Based Medicine
Humans
Infant
Infant, Newborn
Infant, Newborn, Diseases - drug therapy
Infant, Newborn, Diseases - mortality
Infant, Premature
Infant, Premature, Diseases - drug therapy
Infant, Premature, Diseases - mortality
Intensive Care Units, Neonatal
Multicenter Studies as Topic - standards
Practice Guidelines as Topic
Quality of Health Care - standards
Research Design - standards
Treatment Outcome
United States
title Clinical Trial Design in Neonatal Pharmacology: Effect of Center Differences, With Lessons From the Pediatric Oncology Cooperative Research Experience
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