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Response biomarkers in neonatal intervention studies
Lauren E Kelly1, Kimberly Caswell2, Mary A Short3
1Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.
Pediatric Research
|December 27, 2017
Summary
Most neonatal intensive care unit (NICU) drugs lack testing. This review found significant variability in how response biomarkers are reported in neonatal clinical trials, hindering drug development.
Area of Science:
- Neonatal pharmacology
- Biomarker research
- Clinical trial methodology
Background:
- Up to 90% of drugs used in neonatal intensive care units (NICUs) lack clinical testing for safety and efficacy.
- Developing and validating neonatal response biomarkers is crucial for advancing drug development.
- This review assesses the quality of response biomarker reporting in neonatal clinical trials.
Purpose of the Study:
- To evaluate the quality of response biomarker reporting in neonatal clinical trials.
- To identify common practices and areas for improvement in biomarker reporting.
Main Methods:
- A validated literature search strategy was employed.
- Prospective neonatal intervention studies reporting response biomarkers published in 2014 were included.
- Data extraction was performed independently and in duplicate.
Main Results:
- 167 prospective neonatal trials were analyzed, with 35% reporting response biomarkers.
- 275 biomarkers were identified for measuring response (pharmacodynamics and safety).
- Heart rate and oxygen saturation were most common; measurement and instrumentation data were often missing.
Conclusions:
- Significant variability exists in the selection, measurement, and reporting of neonatal response biomarkers.
- Improved reporting initiatives are necessary to reduce research waste.
- Enhancing biomarker reporting will improve the reproducibility of their use in neonatal studies.
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