Evidence map›Paper›PMID 25452025›Full record

ReviewBrain research2015

Use of biomarkers in ALS drug development and clinical trials.

Nadine Bakkar, Ashley Boehringer, Robert Bowser

Open access · greenAbstract readReview
In one paragraph

Review in Brain research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 10% 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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
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  7. Proteinopathies associated to repeat expansion disorders.Journal of neural transmission (Vienna, Austria : 1996) · 2022
    Review
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  19. Drug discovery and development for rare genetic disorders.American journal of medical genetics. Part A · 2017
    Review
  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

3 authors at 2 institutions in 1 country.

Nadine BakkarDivisions of Neurology and Neurobiology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, AZ 85013, USA.
Ashley BoehringerDivisions of Neurology and Neurobiology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, AZ 85013, USA.
Robert BowserDivisions of Neurology and Neurobiology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, AZ 85013, USA. Electronic address: Robert.Bowser@Dignityhealth.org.
Barrow Neurological Institute · USSt. Joseph's Hospital and Medical Center · US

Funding

Peptide and Protein Biomarkers for Amyotrophic Lateral Sclerosis (ALS)R01NS061867 · NINDS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BOWSER, ROBERT P · 2009 to 2013
$1.6M
Multi-Center Validation of Biomarkers for Motor Neuron DiseaseRC1NS068179 · NINDS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BOWSER, ROBERT P, CUDKOWICZ, MERIT E · 2009 to 2010
$977k
Peptide and Protein Biomarkers for Amyotrophic Lateral Sclerosis (ALS)R56NS061867 · NINDS · ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER · PI BOWSER, ROBERT P · 2014 to 2014
$687k
NINDS NIH HHS NS061867NINDS NIH HHS NS068179NINDS NIH HHS R01 NS061867NINDS NIH HHS R56 NS061867NINDS NIH HHS RC1 NS068179
6 · The paper itself

Abstract

The past decade has seen a dramatic increase in the discovery of candidate biomarkers for ALS. These biomarkers typically can either differentiate ALS from control subjects or predict disease course (slow versus fast progression). At the same time, late-stage clinical trials for ALS have failed to generate improved drug treatments for ALS patients. Incorporation of biomarkers into the ALS drug development pipeline and the use of biologic and/or imaging biomarkers in early- and late-stage ALS clinical trials have been absent and only recently pursued in early-phase clinical trials. Further clinical research studies are needed to validate biomarkers for disease progression and develop biomarkers that can help determine that a drug has reached its target within the central nervous system. In this review we summarize recent progress in biomarkers across ALS model systems and patient population, and highlight continued research directions for biomarkers that stratify the patient population to enrich for patients that may best respond to a drug candidate, monitor disease progression and track drug responses in clinical trials. It is crucial that we further develop and validate ALS biomarkers and incorporate these biomarkers into the ALS drug development process. This article is part of a Special Issue entitled ALS complex pathogenesis.

Indexed as

Clinical Trials as TopicAmyotrophic Lateral SclerosisAnimalsBiomarkersDrug DiscoveryHumansPrognosisBiomarkersALSBiomarkersClinical trialPharmacodynamic biomarkerPrognostic biomarker

Identifiers

PMID25452025
PMCPMC4809521
OpenAlexW2002071227

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.