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 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.
Moran
C
C
Department of Pediatrics, Duke University, Durham, North Carolina, USA.
Smith
P B
PB
Cohen-Wolkowiez
M
M
Benjamin
D K
DK
D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000592:standards; D003299:Cooperative Behavior; D019317:Evidence-Based Medicine; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy* / Q000401:mortality; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000188:drug therapy* / Q000401:mortality; D007363:Intensive Care Units, Neonatal; D015337:Multicenter Studies as Topic / Q000592:standards; D017410:Practice Guidelines as Topic; D011787:Quality of Health Care / Q000592:standards; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome; D014481:United States