Evidence map›Paper›PMID 38983658›Full record

ReviewWorld journal of methodology2024

Did pediatric drug development advance epilepsy treatment in young patients? It is time for new research goals.

Earl B Ettienne, Emilio Russo, Pasquale Striano, Jane M Grant-Kels, Klaus Rose

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in World journal of methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Earl B EttienneCollege of Pharmacy, Howard University College of Pharmacy, Washington, DC 20059, United States.
Emilio RussoDepartment of Health Sciences, School of Medicine, Russo, University "Magna Graecia" of Catanzaro, Catanzaro 88100, Italy.
Pasquale StrianoIRCCS Istituto Giannina Gaslini, Genova 16148, Italy.
Jane M Grant-KelsDepartment of Dermatology, University of Connecticut Health Center, Farmington, CT 06032, United States.
Klaus Roseklausrose Consulting, Pediatric Drug Development and more, Medical Science, CH-4125 Riehen, Switzerland. klaus.rose@klausrose.net.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Modern drugs have changed epilepsy, which affects people of all ages. However, for young people with epilepsy, the framework of drug development has stalled. In the wake of the thalidomide catastrophe, the misconception emerged that for people < 18 years of age drugs, including antiseizure medications (ASMs), need separate proof of efficacy and safety, overall called "pediatric drug development". For ASMs, this has changed to some degree. Authorities now accept that ASMs are effective in < 18 years as well, but they still require "extrapolation of efficacy," as if minors were another species. As a result, some of the pediatric clinical epilepsy research over the past decades was unnecessary. Even more importantly, this has hampered research on meaningful research goals. We do not need to confirm that ASMs work before as they do after the 18

Indexed as

Antiseizure medicationsClinical pharmacologyEpilepsyPediatric drug developmentPediatric investigation planTherapeutic orphans

Identifiers

PMID38983658
PMCPMC11229878

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.