Evidence map›Paper›PMID 23861075›Full record

ArticleALTEX2013

Look back in anger - what clinical studies tell us about preclinical work.

Thomas Hartung

Open access · goldAbstract read
In one paragraph

Article in ALTEX, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 2 pooled it
27.2field-weighted citation impact, top 1% 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

71 citing papers in PubMed, 2 syntheses or guidelines pooled it, 193 citations in OpenAlex.

  1. Pooled it
  2. Advances in Engineering Human Tissue Models.Frontiers in bioengineering and biotechnology · 2020
    Pooled it
  3. Article
  4. FXR and BET signaling orchestrate to protect β cells.bioRxiv : the preprint server for biology · 2026
    Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. A New Strategy for Animal Research: Attending to Dissent.Animals : an open access journal from MDPI · 2023
    Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. Article

11 more citing papers are in PubMed but not listed here.

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 2 countries.

Thomas HartungJohns Hopkins University, Bloomberg School of Public Health, CAAT, Baltimore, MD 21205, USA. thartung@jhsph.edu
University of Konstanz · DE

Funding

Mapping the Human Toxome by Systems ToxicologyR01ES020750 · NIEHS · JOHNS HOPKINS UNIVERSITY · PI HARTUNG, THOMAS · 2011 to 2015
$6.0M
A 3D Model of Human Brain Development for Studying Gene/Environment InteractionsU18TR000547 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HARTUNG, THOMAS · 2012 to 2013
$865k
Developmental neurotoxicity pathways for high throughput testing by metabolomicsU01FD004230 · FDA · JOHNS HOPKINS UNIVERSITY · PI HARTUNG, THOMAS · 2011 to 2012
$815k
FDA HHS U01 FD004230FDA HHS U01FD004230NCATS NIH HHS U18 TR000547NCATS NIH HHS U18TR000547NIEHS NIH HHS R01 ES020750NIEHS NIH HHS R01ES020750
6 · The paper itself

Abstract

unlabelledMisled by animal studies and basic research? Whenever we take a closer look at the outcome of clinical trials in a field such as, most recently, stroke or septic shock, we see how limited the value of our preclinical models was. For all indications, 95% of drugs that enter clinical trials do not make it to the market, despite all promise of the (animal) models used to develop them. Drug development has started already to decrease its reliance on animal models: In Europe, for example, despite increasing R&D expenditure, animal use by pharmaceutical companies dropped by more than 25% from 2005 to 2008. In vitro studies are likewise limited: questionable cell authenticity, over-passaging, mycoplasma infections, and lack of differentiation as well as non-homeostatic and non-physiologic culture conditions endanger the relevance of these models. The standards of statistics and reporting often are poor, further impairing reliability. Alarming studies from industry show miserable reproducibility of landmark studies. This paper discusses factors contributing to the lack of reproducibility and relevance of pre-clinical research. THE

conclusionPublish less but of better quality and do not rely on the face value of animal studies.

Indexed as

Animal ExperimentationAnimalsAnimal Testing AlternativesConflict of InterestData Interpretation, StatisticalDrug ApprovalDrug Evaluation, PreclinicalDrug IndustryEuropeHumansMutagenicity TestsResearch DesignToxicity TestsUnited StatesUnited States Food and Drug Administration

Identifiers

PMID23861075
PMCPMC3790571
OpenAlexW170267546

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.