Evidence map›Paper›PMID 34498227›Full record

ArticleTherapeutic innovation & regulatory science2021

Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans.

Dominik Karres, Gregory Reaman, Franca Ligas, Giovanni Lesa, Susan McCune, Suzanne Malli, Ralph Bax, Jean Temeck

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

8 authors.

Dominik KarresPaediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands. Dominik.Karres@ema.europa.eu.
Gregory ReamanOncology Center of Excellence, Office of the Commissioner, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, USA.
Franca LigasPaediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands.
Giovanni LesaPaediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands.
Susan McCuneOffice of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA), Silver Spring, USA.
Suzanne MalliOffice of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA), Silver Spring, USA.
Ralph BaxPaediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands.
Jean TemeckOffice of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA), Silver Spring, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this document is to guide deliberations and permit focused discussions at the monthly paediatric cluster calls, allowing early regulatory coordination of global development plans. The differences in regulations related to timeline are not considered posing a barrier in that regard.

Indexed as

Drug DevelopmentNeoplasmsChildHumansSocial PlanningUnited StatesUnited States Food and Drug Administration

Identifiers

PMID34498227
PMCPMC9437832

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.