ReviewClinical pharmacology and therapeutics2026
Biomarker Utilization for Regulatory Decision Making: A Landscape Analysis of Neurological Drug Products Approved by FDA (2008-2024).
Review in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed.
- Omics Biomarkers in Precision Oncology: From the Lens of the ASCPT Biomarkers and Translational Tools and Oncology Communities.Clinical and translational science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Over the past 15 years, biomarkers have evolved into a significant component of neurological drug development and regulatory evaluation, with expanded roles and increasing impact. This landscape analysis covers new molecular entity (NME) products approved by Food and Drug Administration from 2008 to 2024 for neurological diseases, which demonstrates the growing utilization of biomarkers in regulatory decision making. This includes their use as surrogate endpoints, confirmatory evidence, and basis for dose selection. Our analysis suggested prominent roles of biomarkers in various therapeutic modalities, including small molecules, oligonucleotides, and monoclonal antibodies, as well as in the context of rare or slowly progressive diseases. However, several challenges hinder the effective utilization of biomarker data, including lack of established clinical relevance, variability in data quality, and bioanalytical issues. Addressing these challenges will require cross-sector collaboration, rigorous analytical validation, and a clear demonstration of the linkage between biomarker changes and meaningful clinical benefits. By strengthening the evidentiary foundation of biomarker data, stakeholders can accelerate innovative drug development for neurological diseases and other therapeutic areas.
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What OpenQuestion holds
Registered trials
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.