About this Research Topic
Frontiers in Pediatrics is delighted to introduce the 'Clinical Trial Design and Development’ series of article collections.
Randomized clinical trials have changed the face of evidence-based practice in neonatal and perinatal medicine over the past decade or so. The development of new drugs, treatment modalities, and interventions is entirely reliant on the data from robust, well-designed clinical trials. Whilst the underlying principles of the pharmaceutical pipeline are well understood, trial design and protocol vary greatly with drug class, outcome measures and patient population.
Another facet that will greatly impact evidence-based practice in the future is “big data”, which incorporates the three Vs: “high-volume, high-velocity, and high-variety” of information.
Although clinical trials and big data open huge opportunities for collaboration and cooperation in neonatal and perinatal medicine, there are yet enormous challenges that demand cost-effective and innovative solutions.
In perinatal medicine, neonatology, and pediatrics, there are particular challenges to clinical trial design, from patient enrolment to safety and ethical concerns.
This Research Topic aims to capture clinical trial study protocol designs, original articles and review articles on developments and controversies in the design of clinical trials in neonatology.
It welcomes a broad range of topics in clinical trials, big data, data-driven sciences, and their various applications and challenges in relation to neonatal and perinatal research with particular emphasis on:
• Multi- and international clinical trials
• Big data and machine learning
• Evidence-based medicine practice
• International collaboration
• Neonatal Adverse event reporting
• Safety and risk management for clinical trial participants
• Ethical concerns in trial design
• Recruitment of participants
• Outcome measures in clinical patients
• Core outcome in neonatology and paediatrics
• Full study protocols
• Regulatory aspects of neonatal clinical trials
• Pharmacokinetics and pharmacodynamics in neonatal clinical trials
• Long-term follow-up of neonatal clinical trials
• Alternative study designs to facilitate neonatal clinical trials
Randomized clinical trials have changed the face of evidence-based practice in neonatal and perinatal medicine over the past decade or so. The development of new drugs, treatment modalities, and interventions is entirely reliant on the data from robust, well-designed clinical trials. Whilst the underlying principles of the pharmaceutical pipeline are well understood, trial design and protocol vary greatly with drug class, outcome measures and patient population.
Another facet that will greatly impact evidence-based practice in the future is “big data”, which incorporates the three Vs: “high-volume, high-velocity, and high-variety” of information.
Although clinical trials and big data open huge opportunities for collaboration and cooperation in neonatal and perinatal medicine, there are yet enormous challenges that demand cost-effective and innovative solutions.
In perinatal medicine, neonatology, and pediatrics, there are particular challenges to clinical trial design, from patient enrolment to safety and ethical concerns.
This Research Topic aims to capture clinical trial study protocol designs, original articles and review articles on developments and controversies in the design of clinical trials in neonatology.
It welcomes a broad range of topics in clinical trials, big data, data-driven sciences, and their various applications and challenges in relation to neonatal and perinatal research with particular emphasis on:
• Multi- and international clinical trials
• Big data and machine learning
• Evidence-based medicine practice
• International collaboration
• Neonatal Adverse event reporting
• Safety and risk management for clinical trial participants
• Ethical concerns in trial design
• Recruitment of participants
• Outcome measures in clinical patients
• Core outcome in neonatology and paediatrics
• Full study protocols
• Regulatory aspects of neonatal clinical trials
• Pharmacokinetics and pharmacodynamics in neonatal clinical trials
• Long-term follow-up of neonatal clinical trials
• Alternative study designs to facilitate neonatal clinical trials
Keywords: trial, analysis, neonate, perinatal, random, data, safety, ethics
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
