Evidence map›Paper›PMID 25592627›Full record

ArticleExperimental neurology2015

How clinical trials of myasthenia gravis can inform pre-clinical drug development.

Anna Rostedt Punga, Henry J Kaminski, David P Richman, Michael Benatar

Abstract read
In one paragraph

Article in Experimental neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  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

4 authors at 4 institutions in 2 countries.

Anna Rostedt PungaInstitute of Neuroscience, Department of Clinical Neurophysiology, Uppsala University, Uppsala, Sweden.
Henry J KaminskiDepartment of Neurology, George Washington University, Washington DC, USA. Electronic address: HKaminski@mfa.gwu.edu.
David P RichmanDepartment of Neurology, University of California Davis School of Medicine, Davis, CA, USA.
Michael BenatarDepartment of Neurology, University of Miami Miller School of Medicine, Miami, FL, USA.
George Washington University · USUniversity of California, Davis · USUniversity of Miami · USUppsala University · SE

Funding

Targeted Therapies for Myasthenia GravisR24EY014837 · NEI · SAINT LOUIS UNIVERSITY · PI KAMINSKI, HENRY J · 2003 to 2007
$4.9M
Intramural NIH HHS Z99 NS999999NEI NIH HHS R24 EY014837
6 · The paper itself

Abstract

Pre-clinical evaluations often provide the rationale for therapeutic assessments in humans; however, in many diseases an agent found successful in animal models does not show efficacy in human subjects. Our contention is that the approach of rigorous, clinical trials can be used to inform how preclinical assessments should be performed. Clinical trials in humans are carefully designed investigations executed with consideration of critical methodological issues, such as pre-specified entrance criteria and validated, outcome measures coupled with power analysis to identify sample size. Blinding of evaluators of subjective measures and randomization of subjects are also critical aspects of trial performance. Investigative agents are also tested in subjects with active disease, rather than prior to disease induction as in some pre-clinical assessments. Application of standard procedures, including uniform reporting standards, would likely assist in reproducibility of pre-clinical experiments. Adapting methods of clinical trial performance will likely improve the success rate of therapeutics to ultimately achieve human use.

Indexed as

Disease Models, AnimalMyasthenia GravisAnimalsClinical Trials as TopicDrug Evaluation, PreclinicalHumansResearch DesignAnimal modelsClinical trialsMyasthenia gravisPreclinical assessmentTherapeutic development

Identifiers

PMID25592627
PMCPMC4466144
OpenAlexW1985913964

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.