With the increasing volume of clinical evidence derived from large‐scale Asian real‐world data (RWD) and the growing interest in its use in regulatory decision‐making, it is important to conduct benchmarking exercises that evaluate whether studies using Asian RWD can generate similar conclusions as randomized controlled trials (RCTs).
Hwa Yeon Ko +15 more
wiley +1 more source
Major Adverse Cardiac Events with Ondansetron: A Systematic Review
Evidence base: 170 randomized trials, 23,421 adults, predominantly single‐dose IV ondansetron, mean follow‐up 20 days. Observed outcomes: Major adverse cardiac events were rare, no ventricular arrhythmias or torsades de pointes observed. Conclusion: Ondansetron was not associated with increased mortality or serious cardiac arrhythmias in adult ...
Michael Cristian Garcia +11 more
wiley +1 more source
A Novel Neurocosmetic Postprocedure Cream for Optimal Recovery and Tolerability From Energy-Based Devices. [PDF]
Weir NM, Burns AJ, Kononov T, Zahr AS.
europepmc +1 more source
Population Pharmacokinetics of Clesrovimab in Preterm and Full‐Term Infants
Clesrovimab is a half‐life extended monoclonal antibody targeting the respiratory syncytial virus fusion protein. Three studies (phase Ib/IIa [MK‐1654‐002], phase IIb/III [CLEVER], and phase III [SMART]) were conducted to evaluate the efficacy, safety, and pharmacokinetics (PK) of clesrovimab in infants.
Ziheng Hu +8 more
wiley +1 more source
External comparator cohort (ECC) studies with real‐world data (RWD) may provide more reliable estimates of treatment differences compared to single‐arm trials (SAT), yet they face limitations such as selection bias and data heterogeneity. This study assessed the perceived strength of evidence of ECC studies compared to SAT and randomized controlled ...
Francesco Pignatti +19 more
wiley +1 more source
Effectiveness of axicabtagene ciloleucel versus conventional treatments as first-line therapy for high-risk large B-cell lymphoma: an external comparator study. [PDF]
Kim JH +6 more
europepmc +1 more source
Children’s services assessment for 2011: arrangements and guidance for local authorities and their partners on Ofsted’s annual assessment of children’s services [PDF]
core
Pregabalin and duloxetine are widely prescribed non‐opioid medications for chronic musculoskeletal pain. Pregabalin may increase the risk of heart failure, and duloxetine increases heart rate and blood pressure; however, little is known about their comparative cardiovascular safety.
Sachalee Campbell +11 more
wiley +1 more source
Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD). [PDF]
Coste A +4 more
europepmc +1 more source

