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©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. Jun 20, 2024; 14(2): 92371
Published online Jun 20, 2024. doi: 10.5662/wjm.v14.i2.92371
Published online Jun 20, 2024. doi: 10.5662/wjm.v14.i2.92371
Did pediatric drug development advance epilepsy treatment in young patients? It is time for new research goals
Earl B Ettienne, College of Pharmacy, Howard University College of Pharmacy, Washington, DC 20059, United States
Emilio Russo, Department of Health Sciences, School of Medicine, Russo, University "Magna Graecia" of Catanzaro, Catanzaro 88100, Italy
Pasquale Striano, IRCCS Istituto Giannina Gaslini, Genova 16148, Italy
Jane M Grant-Kels, Department of Dermatology, University of Connecticut Health Center, Farmington, CT 06032, United States
Klaus Rose, klausrose Consulting, Pediatric Drug Development and more, Medical Science, CH-4125 Riehen, Switzerland
Author contributions: The idea for this manuscript emerged in correspondence and discussion of all involved authors. Rose K circulated a first draft which was critically reviewed and amended by all other authors; Grant-Kels JM, Ettienne EB, Russo E, and Striano P edited the English language; Rose K wrote the final manuscript based on feedback from all other authors; Grant-Kels JM did a final English language polishing. The final manuscript was circulated and approved by all co-authors.
Conflict-of-interest statement: The authors declare no conflict of interest.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Klaus Rose, MD, MS, CEO, klausrose Consulting, Pediatric Drug Development and more, Medical Science, Äussere Baselstrasse 308, CH-4125 Riehen, Switzerland. klaus.rose@klausrose.net
Received: January 23, 2024
Revised: February 13, 2024
Accepted: April 16, 2024
Published online: June 20, 2024
Processing time: 142 Days and 18.2 Hours
Revised: February 13, 2024
Accepted: April 16, 2024
Published online: June 20, 2024
Processing time: 142 Days and 18.2 Hours
Core Tip
Core Tip: For young people with epilepsy, the framework of drug development has stalled. The misconception emerged that for people < 18 years drugs, including antiseizure medications (ASMs), need separate proof of efficacy and safety, overall called "pediatric drug development". For ASMs, the authorities require "extrapolation of efficacy", as if minors were another species. Relevant parts of pediatric epilepsy research were pointless, and research on meaningful goals was hampered. ASMs work also before the 18th birthday. We should learn to prevent brain damage in young patients by preventing seizures and by optimize ASMs’ use.