ReviewBiomarker insights2020
Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape.
Review in Biomarker insights, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 2 of them syntheses that pooled 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.
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
45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 92 citations in OpenAlex.
- Parameter Space and Potential for Biomarker Development in 25 Years of fMRI Drug Cue Reactivity: A Systematic Review.JAMA psychiatry · 2024Pooled it
- Pooled it
- More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations.Clinical pharmacology and therapeutics · 2026Review
- Biomarker-Guided Drug Delivery Systems and Oral Bioavailability Enhancement.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Biomarker Utilization for Regulatory Decision Making: A Landscape Analysis of Neurological Drug Products Approved by FDA (2008-2024).Clinical pharmacology and therapeutics · 2026Review
- Milestone to Ensure Safety and Efficacy of Companion Diagnostic (CDx) That Support Treatment Decisions in Cancer Patients.Diagnostics (Basel, Switzerland) · 2026Review
- Biomarkers of treatment response in rheumatoid arthritis: from conventional markers to tissue immunophenotype.Frontiers in immunology · 2026Review
- Unmet need for biomarkers in chronic cough: a review of current challenges and future directions.ERJ open research · 2025Review
- Use of Proteomics to Explore Biomarkers of Amyotrophic Lateral Sclerosis (ALS): Proof of Principle from Humanized SOD1 Mouse to Human ALS.ACS pharmacology & translational science · 2025Review
- Advancements in Biomarkers for Early Detection and Risk Stratification of Cardiovascular Diseases-A Literature Review.Health science reports · 2025Article
- Polymerase Chain Reaction Chips for Biomarker Discovery and Validation in Drug Development.Micromachines · 2025Review
- Bridging the gap: From petri dish to patient - Advancements in translational drug discovery.Heliyon · 2025Review
- UPLC-MS/MS High-Risk Screening for Sphingolipidoses Using Dried Urine Spots.Biomolecules · 2024Article
- Neuroimaging Biomarkers in Addiction.medRxiv : the preprint server for health sciences · 2024Article
- Challenges in IBD Research 2024: Precision Medicine.Inflammatory bowel diseases · 2024Review
- Amoxicillin/clavulanate in combination with rifampicin/clarithromycin is bactericidal against Mycobacterium ulcerans.PLoS neglected tropical diseases · 2024Article
- Combining causal and correlative approaches to discover biomarkers of response to paclitaxel.Oncotarget · 2024Article
- Roadmap to DILI research in Europe. A proposal from COST action ProEuroDILINet.Pharmacological research · 2024Article
- From multi-omics to predictive biomarker: AI in tumor microenvironment.Frontiers in immunology · 2024Review
- NeuroToolKit Data Hackathon: advancing data collaboration in Alzheimer's disease.Frontiers in neuroscience · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biomarkers are widely used at every stage of drug discovery and development. Utilisation of biomarkers has a potential to make drug discovery, development and approval processes more efficient. An overview of the current global regulatory landscape is presented in this article with particular emphasis on the validation and qualification of biomarkers, as well as legal framework for companion diagnostics. Furthermore, this article shows how the number of approved drugs with at least 1 biomarker used during development (biomarker acceptance) is affected by the recent advances in the biomarker regulations. More than half of analysed approvals were supported by biomarker data and there has been a slight increase in acceptance of biomarkers in recent years, even though the growth is not continuous. For certain pharmacotherapeutic groups, approvals with biomarkers are more common than without. Examples include immunosuppressants, immunostimulants, drugs used in diabetes, antithrombotic drugs, antineoplastic agents and antivirals. As a conclusion, potential benefits, challenges and opportunities of using biomarkers in drug discovery and development in the current regulatory landscape are summarised and discussed.
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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.