Response biomarkers in neonatal intervention studies
Autor: | Martin Offringa, Kimberly Caswell, Mary A Short, Prabhu S. Parimi, Lauren E. Kelly, Thomas G. Diacovo |
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Rok vydání: | 2017 |
Předmět: |
medicine.medical_specialty
Infant Newborn Diseases 03 medical and health sciences 0302 clinical medicine Heart Rate Intensive Care Units Neonatal 030225 pediatrics Intensive care Humans Medicine Prospective Studies 030212 general & internal medicine Intensive care medicine Pharmaceutical industry Clinical Trials as Topic business.industry Infant Newborn Reproducibility of Results Intervention studies Oxygen Clinical trial Drug development Drug Design Pharmacodynamics Pediatrics Perinatology and Child Health Biomarker (medicine) Neonatology business Biomarkers Infant Premature |
Zdroj: | Pediatric Research. 83:425-430 |
ISSN: | 1530-0447 0031-3998 |
Popis: | BackgroundUp to 90% of all drugs used in neonatal intensive care units (NICUs) have not been clinically tested for safety and efficacy. To promote drug development for neonates, the pharmaceutical industry is moving toward rigorous testing, necessitating the need to development, and validating biomarkers in neonates to predict their response. The objective of this review is to evaluate the quality of the response biomarker reporting in neonatal clinical trials.MethodsA validated literature search strategy was applied. Prospective neonatal intervention studies reporting response biomarkers published in 2014 were included. The data were extracted independently and in duplicate using a data-extraction form.ResultsFollowing the full-text review, 167 published prospective neonatal trials were included; 35% (59/167) reported the use of response biomarkers. In these 59 trials, we identified 275 biomarkers used to measure the response (pharmacodynamics and safety) reported as primary or secondary outcomes. Heart rate and oxygen saturation were the most commonly reported. Measurement and instrumentation data were often not provided.ConclusionWe identified a huge variability in the selection, measurement, and reporting of neonatal response biomarkers in prospective intervention studies. Reporting initiatives are needed to reduce research waste and improve the reproducibility of biomarker use in neonatal intervention studies. |
Databáze: | OpenAIRE |
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