Evidence map›Paper›PMID 40955802›Full record

ArticleBiomarkers in medicine2025

Trends in clinical studies evaluating neurofilament light chain as a biomarker.

Sydney Stern, Kristin Jamenis, Sreedharan Sabarinath, Shawna L Weis, Robert Schuck, Michael Pacanowski

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Biomarkers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Review
  2. Review
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

6 authors.

Sydney SternCenter for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-1479-605X
Kristin JamenisCenter for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-0055-4973
Sreedharan SabarinathCenter for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0006-0392-4366
Shawna L WeisCenter for Drug Evaluation and Research, Office of New Drugs, Office of Rare Diseases, Pediatric, Urologic and Reproductive Medicine, US Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0008-1917-3194
Robert SchuckCenter for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-5855-1361
Michael PacanowskiCenter for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0004-2620-7779

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

introductionThe use of biomarkers as surrogate endpoints, supported by strong mechanistic, epidemiologic, and/or clinical data, provides drug development programs with endpoints that predict clinical benefit and may be more sensitive to drug effects than clinical endpoints. Neurofilament light chain (NfL) is a marker of neuroaxonal injury that has emerged as a promising biomarker for neurodegenerative diseases.

methodsWe identified Investigational New Drug programs submitted to the U.S. Food and Drug Administration between 2005-2024 that proposed to use NfL as a pharmacodynamic biomarker, biomarker for patient selection or stratification, and/or surrogate endpoint for accelerated approval.

resultsA total of 50 programs were identified with most from the last five years. Of the 50 programs, 94% (

conclusionThis analysis highlights the important role that NfL plays in clinical trials and identifies future areas of research and study design considerations to strengthen the support of NfL as a biomarker.

Indexed as

BiomarkersNeurofilament ProteinsClinical Trials as TopicHumansNeurodegenerative DiseasesUnited StatesUnited States Food and Drug AdministrationBiomarkersneurofilament protein LNeurofilament ProteinsBiomarkerclinical trialsdrug developmentneurofilament light chainpharmacodynamicsurrogate endpoint

Identifiers

PMID40955802
PMCPMC12453014

What Socratic 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 Socratic graph.