Evidence map›Paper›PMID 15717019›Full record

ReviewNeuroRx : the journal of the American Society for Experimental NeuroTherapeutics2004

Biomarkers and surrogate markers: an FDA perspective.

Russell Katz

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in NeuroRx : the journal of the American Society for Experimental NeuroTherapeutics, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 136 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
136citing papers in PubMed, 7 pooled it
–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

136 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Quantitative clinical characteristics of 53 patients with MPS VII: a cross-sectional analysis.Genetics in medicine : official journal of the American College of Medical Genetics · 2017
    Pooled it
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  5. Early change in proteinuria as a surrogate end point for kidney disease progression: an individual patient meta-analysis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2014
    Pooled it
  6. Pooled it
  7. Guideline
  8. Trial
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  13. Serum PARC/CCL-18 concentrations and health outcomes in chronic obstructive pulmonary disease.American journal of respiratory and critical care medicine · 2011
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  16. Operationalizing Alzheimer's disease trials in the era of targeted therapies.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Review
  17. Article
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  20. Article

76 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.

Russell KatzDivision of Neuropharmacological Drug Products, United States Food and Drug Administration, Rockville, Maryland 20852, USA. katzr@cder.fda.gov

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Interest is increasing rapidly in the use of surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials. Many such surrogate markers have been proposed as potential candidates for use in definitive effectiveness trials of agents to treat neurologic or psychiatric disease, but as of this date, there are no such markers that have been adequately "validated," that is, shown to predict the effect of the treatment on the clinical outcome of interest. While the current law and regulations permit the United States Food and Drug Administration to base the approval of a drug product on a determination the effect of the drug on an unvalidated surrogate marker (that is, one for which it is not known that an effect on the surrogate actually predicts the desired clinical benefit), there are a number of difficulties in interpreting trials that use surrogate markers as primary measures of drug effect. In this article, the relevant regulatory context will be discussed, as well as the epistemological problems related to the interpretation of clinical trials in which unvalidated surrogate markers are used as primary outcomes.

Indexed as

BiomarkersClinical Trials as TopicHumansUnited StatesUnited States Food and Drug AdministrationBiomarkers

Identifiers

PMID15717019
PMCPMC534924

What OpenQuestion holds

Textmetadata
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.