Vera Ignjatović: How Do We Rigorously Study These Drugs in Children to Understand Their True Benefits and Risks?
Vera Ignjatović, Founder and Managing Director at Ignis Innovations Pty Ltd, Principal Consultant of Translational Research at Johns Hopkins All Children’s Hospital, shared on LinkedIn about a recent article by Neil A. Goldenberg, published in JTH, adding:
“Children with blood clots deserve better, and that starts with drugs actually designed and tested for them.
The truth is, most antithrombotic drugs children receive today were developed for adults.
Heparins and warfarin have been the backbone of treatment for over half a century, with a wave of newer agents opening new possibilities.
The critical question is: how do we rigorously study these drugs in children to understand their true benefits and risks?
Our new guidance paper provides expert guidance on exactly that – the rigorous study of antithrombotic drugs, from trial design and endpoint selection to regulatory strategy and real-world effectiveness.
Behind this work is a growing international community (Pedi-ATLAS and the ISTH Pediatric/Neonatal SSC) committed to ensuring that pediatric patients never simply an afterthought in drug development.
Because children are Not small adults.
They deserve science built for them!
‘Development of New Antithrombotic Drugs for Children (Part ), guidance from the International Society on Thrombosis and Haemostasis (ISTH) Scientific Standardization Committee Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis and the Pedi-ATLAS Group’
Neil Goldenberg MD PhD, Marisol Betensky, Scott D Berkowitz, MD, Susanne Holzhauer, Amy K., Daniel Schaufelberger, PhD, Paul Monagle MD, Christoph Male MD, Antithrombotic Trials Working Party of ISTH SSC Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis”
Title: Development of new antithrombotic drugs for children (part ): guidance from the ISTH SSC Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis and the Pedi-ATLAS Group
Authors: Neil A. Goldenberg, Scott D. Berkowitz, Marisol Betensky, Susanne Holzhauer, Vera Ignjatovic, Amy Kiskaddon, Daniel Schaufelberger, Paul Monagle, Christoph Male 8Antithrombotic Trials Working Party of ISTH SSC Subcommittee on Pediatric and Neonatal Thrombosis and Hemostasis
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