Evidence map›Paper›PMID 41258753›Full record

ArticleClinical pharmacology and therapeutics2025

Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?

Gilbert J Burckart, Susan M Abdel-Rahman, Gelareh Abulwerdi, Sherbet Samuels, Rebecca Racz, Mohamed A Mohamoud, Nicholas P Tatonetti

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Article
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

7 authors.

Gilbert J BurckartOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0003-2005-9301
Susan M Abdel-RahmanOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-5815-2029
Gelareh AbulwerdiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-1036-6378
Sherbet SamuelsOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0009-0001-1569-6157
Rebecca RaczOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-5487-5692
Mohamed A MohamoudOffice of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-5997-4876
Nicholas P TatonettiDepartment of Computational Biomedicine, Cedars-Sinai Medical Center, West Hollywood, California, USA.ORCID https://orcid.org/0000-0002-2700-2597

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental processes. The realization of this risk comes with the understanding that we could not predict another thalidomide worldwide tragedy even 70 years later.

Identifiers

PMID41258753
PMCPMC12954531

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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 Socratic graph.