Evidence map›Paper›PMID 20228942›Full record

ArticleExpert review of clinical pharmacology2009

Challenges in conducting clinical trials in children: approaches for improving performance.

Steven E Kern

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Expert review of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% of its field
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

46 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Activity and toxicity of intramuscular 1000 iu/mBritish journal of haematology · 2022
    Trial
  4. Trial
  5. Challenges in conducting trials for pediatric tuberculous meningitis: lessons from the field.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019
    Trial
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Optimal Dosing Recommendations of Clonidine in Pediatrics Using Physiologically Based Pharmacokinetic Modeling.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. 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

1 author at 1 institution in 1 country.

Steven E KernAssociate Professor of Pharmaceutics and Pharmaceutical Chemistry, Adjunct Associate Professor of Pediatrics and Anesthesiology, Research Associate Professor of Bioengineering, University of Utah, Salt Lake City, UT, USA, Tel.: +1 801 585 5958, , steven.kern@utah.edu.
University of Utah · US

Funding

University of Utah Pediatric Pharmacology Research UnitU10HD045986 · NICHD · UNIVERSITY OF UTAH · PI WARD, ROBERT MARSHALL · 2004 to 2009
$2.1M
NICHD NIH HHS U10 HD045986
6 · The paper itself

Abstract

Recent legislative changes in both Europe and the USA have increased the responsibility of drug developers to purposefully study the agents they market in children so that specific dosing recommendations can be made to assist clinicians in their use. Typically, clinicians use empiricalor experiential-based rationales for selecting the dose to use in children, generally in a manner that attempts to achieve the same dose-exposure or pharmacokinetic profile in children as in adults. However, whether this approach achieves the necessary dose exposure or exposure effect needed may not be systematically explored during off-label use. This creates the opportunity for under- or over-exposure in children, particularly in very young children (i.e., less than 2 years old) where a combination of factors during development can effect both pharmacokinetics and pharmacodynamics. The ethical, physiological and statistical differences of studying new therapeutic agents in children present economic challenges that may create unintended incentives - both positive and negative - for any individual developer who tries to meet the requirements of new legislation to study pharmaceutical agents in children. There should be a continued emphasis in academic clinical pharmacology programs towards creative methods and approaches to better understand these differences in children compared with adults. The ability to use information from knowledge obtained from adult studies, from preclinical studies, from studies of compounds with similar chemistry or pharmacology, or from known physiological differences between children and adults is essential to choosing a suitable dose for children and achieving these regulatory aims.

Identifiers

PMID20228942
PMCPMC2835973
OpenAlexW2092237119

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.