Pharmacology studies can be used to investigate the utilisation, effectiveness, and safety of medications for neonates in real-world settings. Recent advances include US FDA's Real World Data project and their collaboration with the Critical Path Institute (C-Path). The goal is to collect medical records from 1 million newborns worldwide to include clinical data, outcomes and lab data. This will help to provide a normative for laboratory studies, the baseleine frequency of adverse events, and potentially identify factors associated with the development of bronchopulmonary dysplasia, the chronic pulmonary disease associared with extreme prematurity. Because adverse event scoring systems do not detect newborn or infant behaviors, there is interest in utilizing a new scoring system to grade the severity of most adverse events in neonates. The neonatal AE severity scale (NAESS) was developed recently by the Internation Neonatal Consortium (INC) with a team led by Thomas Salaets and Karel Allegaert. The FDA is currently recommending to sponsors that NAESS be used in clinical trials involving neonates.
Database studies are often conducted post-authorisation (when the drugs have already been on the market). The goal is to collect data on their safety and effects during longer periods in larger populations and amongst special populations, such as neonates. However, understanding the benefits and risks of many currently available medications is still inadequately studied in this vulnerable population. The advent of electronic healthcare databases (EHDs) has made it easier to conduct post-authorisation observational studies on medication use, safety, and effectiveness. Linking data from electronic medical records between the mother and neonate can be challenging. EHDs rarely have the exact start or end date of pregnancy, which could include adverse events in neonates; therefore, related laboratory or imaging results and delivery outcomes are still needed.
There is a need to link various sub-databases and develop algorithms for accurately detecting outcomes for neonates within different EHDs. As outlined by the INC, the next step would be to validate the neonatal algorithm against data from healthcare professionals and/or patients. Only then would it be possible to study various drugs' use, effectiveness, or safety using electronic medical records and the validated algorithm.
In this Research Topic, we welcome papers in the broader field of clinical pharmacology with a focus on the following subjects:
• Developing new (or improving current) algorithms for detecting adverse events in an EHD
• Validation studies on current (or new) neonatal algorithms in an EHD
• Drug utilisation studies using electronic medical records
• Drug safety studies using electronic medical records
• Studies on adverse drug reactions or drug-drug interactions using data from EHDs
We welcome full research papers, brief reports, reviews and correspondences from areas such as methodologies or clinical research on the above subjects related to the safe and effective use of medications. These can be sourced from research networks, academics, regulatory agencies, policy-makers, pharmaceutical companies, and other institutions interested in the safety and effective use of medications in neonates.
Pharmacology studies can be used to investigate the utilisation, effectiveness, and safety of medications for neonates in real-world settings. Recent advances include US FDA's Real World Data project and their collaboration with the Critical Path Institute (C-Path). The goal is to collect medical records from 1 million newborns worldwide to include clinical data, outcomes and lab data. This will help to provide a normative for laboratory studies, the baseleine frequency of adverse events, and potentially identify factors associated with the development of bronchopulmonary dysplasia, the chronic pulmonary disease associared with extreme prematurity. Because adverse event scoring systems do not detect newborn or infant behaviors, there is interest in utilizing a new scoring system to grade the severity of most adverse events in neonates. The neonatal AE severity scale (NAESS) was developed recently by the Internation Neonatal Consortium (INC) with a team led by Thomas Salaets and Karel Allegaert. The FDA is currently recommending to sponsors that NAESS be used in clinical trials involving neonates.
Database studies are often conducted post-authorisation (when the drugs have already been on the market). The goal is to collect data on their safety and effects during longer periods in larger populations and amongst special populations, such as neonates. However, understanding the benefits and risks of many currently available medications is still inadequately studied in this vulnerable population. The advent of electronic healthcare databases (EHDs) has made it easier to conduct post-authorisation observational studies on medication use, safety, and effectiveness. Linking data from electronic medical records between the mother and neonate can be challenging. EHDs rarely have the exact start or end date of pregnancy, which could include adverse events in neonates; therefore, related laboratory or imaging results and delivery outcomes are still needed.
There is a need to link various sub-databases and develop algorithms for accurately detecting outcomes for neonates within different EHDs. As outlined by the INC, the next step would be to validate the neonatal algorithm against data from healthcare professionals and/or patients. Only then would it be possible to study various drugs' use, effectiveness, or safety using electronic medical records and the validated algorithm.
In this Research Topic, we welcome papers in the broader field of clinical pharmacology with a focus on the following subjects:
• Developing new (or improving current) algorithms for detecting adverse events in an EHD
• Validation studies on current (or new) neonatal algorithms in an EHD
• Drug utilisation studies using electronic medical records
• Drug safety studies using electronic medical records
• Studies on adverse drug reactions or drug-drug interactions using data from EHDs
We welcome full research papers, brief reports, reviews and correspondences from areas such as methodologies or clinical research on the above subjects related to the safe and effective use of medications. These can be sourced from research networks, academics, regulatory agencies, policy-makers, pharmaceutical companies, and other institutions interested in the safety and effective use of medications in neonates.
