ArticleBioanalysis2018
Biomarkers in early-phase trials: fundamental issues.
Article in Bioanalysis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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
22 citing papers in PubMed.
- Emerging Anti-Cancer and Repurposed Therapies for Overcoming Multidrug Resistance in Lung Cancer.Medical oncology (Northwood, London, England) · 2025Review
- FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early-Phase Trials Using Innovative Trial Designs and Biomarkers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Clinical pharmacology-how it shapes the drug development journey.European journal of clinical pharmacology · 2025Review
- Remnant cholesterol concentrations best explain the cardiovascular benefit of APOC3 genetic inhibition: a drug target Mendelian randomization study.European heart journal open · 2025Article
- Establishing Decisional Cutoff Values of Neurofilament Light Chains in Cerebrospinal Fluid Measured by Fully Automated Chemiluminescent Enzyme Immunoassay.Journal of clinical laboratory analysis · 2025Observational
- CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.EClinicalMedicine · 2025Article
- SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.EClinicalMedicine · 2025Article
- NCI workshop on ctDNA in cancer treatment and clinical care.Journal of the National Cancer Institute · 2024Article
- Logistic regression and other statistical tools in diagnostic biomarker studies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Review
- Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.BMJ (Clinical research ed.) · 2023Article
- Evaluation of electrolyte element composition in human tissue by laser-induced breakdown spectroscopy (LIBS).Scientific reports · 2022Article
- External Quality Assessment of Maternal Serum Levels of Alpha-Fetoprotein, Free Beta-Human Chorionic Gonadotropin, and Unconjugated Estriol in Detecting Down Syndrome and Neural Tube Defects in the Second Trimester of 87 Maternal Serum Samples, Based on 105-139 Days.Medical science monitor : international medical journal of experimental and clinical research · 2022Article
- A natural history study to track brain and spinal cord changes in individuals with Friedreich's ataxia: TRACK-FA study protocol.PloS one · 2022Article
- Lack of predictive tools for conventional and targeted cancer therapy: Barriers to biomarker development and clinical translation.Advanced drug delivery reviews · 2021Review
- Targeting for Success: Demonstrating Proof-of-Concept with Mechanistic Early Phase Clinical Pharmacology Studies for Disease-Modification in Neurodegenerative Disorders.International journal of molecular sciences · 2021Review
- Characterizing the electrophysiological abnormalities in visually reviewed normal EEGs of drug-resistant focal epilepsy patients.Brain communications · 2021Article
- Clinical proteomics for prostate cancer: understanding prostate cancer pathology and protein biomarkers for improved disease management.Clinical proteomics · 2020Review
- Huntington disease: new insights into molecular pathogenesis and therapeutic opportunities.Nature reviews. Neurology · 2020Review
- Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.Journal of clinical pharmacology · 2019Review
- Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials.Journal of personalized medicine · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biomarkers are frequently being included in early-phase clinical trials. This article is meant to introduce clinical investigators to the fundamentals of choosing a biomarker test for use in an early phase trial. Steps to consider are briefly outlined including defining the role of the biomarker in the early phase trial; selecting a fit-for-purpose biomarker test and laboratory; describing the test procedures; carrying out analytical validation testing appropriate for the research objectives and the risk involved in the trial; implementing the test in the trial; and planning for the future. Examples illustrate analytical validation approaches in the context of typical biomarker roles. The importance of collaboration between clinical investigators and laboratory researchers is emphasized.
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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.