Evidence map›Paper›PMID 30094815›Full record

ReviewClinical pharmacology and therapeutics2019

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.

Dionna J Green, Haihao Sun, Janelle Burnham, Xiaomei I Liu, John van den Anker, Jean Temeck, Lynne Yao, Susan K McCune, Gilbert J Burckart

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Clinical pharmacology and therapeutics, 2019. 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. A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
    Article
  2. The Revolution in Pediatric Drug Development and Drug Use: Therapeutic Orphans No More.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2020
    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

9 authors.

Dionna J GreenOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Haihao SunOffice of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, Maryland, USA.
Janelle BurnhamOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Xiaomei I LiuChildren's National Medical Center, Washington, DC, USA.
John van den AnkerChildren's National Medical Center, Washington, DC, USA.
Jean TemeckOffice of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, Maryland, USA.
Lynne YaoChildren's National Medical Center, Washington, DC, USA.
Susan K McCuneOffice of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, Maryland, USA.
Gilbert J BurckartOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The 21

Indexed as

BiomarkersChildClinical Trials as TopicDrug ApprovalHumansUnited StatesUnited States Food and Drug AdministrationBiomarkers

Identifiers

PMID30094815
PMCPMC6481930

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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 OpenQuestion graph.