Predicting Clinical Outcomes Using Molecular Biomarkers

Over the past 20 years, there has been an exponential increase in the number of biomarkers. At the last count, there were 768,259 papers indexed in PubMed.gov directly related to biomarkers. Although many of these papers claim to report clinically useful molecular biomarkers, embarrassingly few are currently in clinical use. It is suggested that a failure to properly understand, clinically assess, and utilize molecular biomarkers has prevented their widespread adoption in treatment, in comparative benefit analyses, and their integration into individualized patient outcome predictions for clinical decision-making and therapy. A straightforward, general approach to understanding how to predict clinical outcomes using risk, diagnostic, and prognostic molecular biomarkers is presented. In the future, molecular biomarkers will drive advances in risk, diagnosis, and prognosis, they will be the targets of powerful molecular therapies, and they will individualize and optimize therapy. Furthermore, clinical predictions based on molecular biomarkers will be displayed on the clinician's screen during the physician–patient interaction, they will be an integral part of physician–patient-shared decision-making, and they will improve clinical care and patient outcomes.

• Publication year

  2016

• Venue

  Biomarkers in Cancer

• Publication date

  2016-01-01

• Fields of study

  Biology, Medicine

• Identifiers
  DOI 10.4137/BIC.S33380PMID 27279751PMCID 4896533
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Prostate Cancer

  2018cited by this paper
• [Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis].

  2018cited by this paper
• Biomarkers in Colorectal Cancer.

  2016cited by this paper
• Novel Molecular Markers for Breast Cancer

  2016cited by this paper
• Prostate cancer

  2016cited by this paper
• Translational progress on tumor biomarkers

  2015cited by this paper
• Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): Explanation and Elaboration

  2015cited by this paper
• The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses.

  2015cited by this paper
• Effect of Ebola Progression in Liberia

  2015cited by this paper
• VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMORS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS

  2013cited by this paper
• Clinical trials for predictive medicine

  2012cited by this paper
• Biomarker studies: a call for a comprehensive biomarker study registry

  2011cited by this paper
• Improving biomarker identification with better designs and reporting.

  2011cited by this paper
• AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug Development

  2010influential reference
• Biomarkers for Colorectal Cancer

  2010cited by this paper
• Organizational issues in providing high-quality human tissues and clinical information for the support of biomedical research.

  2010cited by this paper
• Reporting of prognostic studies of tumour markers: a review of published articles in relation to REMARK guidelines

  2009cited by this paper
• Surrogate and mediating endpoints: current status and future directions.

  2009cited by this paper
• Prognosis and prognostic research: validating a prognostic model

  2009cited by this paper
• Prognosis and prognostic research: application and impact of prognostic models in clinical practice

  2009cited by this paper
• Court hears how drug giant Merck tried to “neutralise” and “discredit” doctors critical of Vioxx

  2009cited by this paper
• Use of archived specimens in evaluation of prognostic and predictive biomarkers.

  2009cited by this paper
• Prognosis and prognostic research: Developing a prognostic model

  2009cited by this paper
• The power of prediction

  2008cited by this paper
• Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design

  2008cited by this paper
• Surrogate endpoints: wishful thinking or reality?

  2008cited by this paper
• An Introduction to the Bootstrap

  2007cited by this paper
• Identity crisis: finding, defining, and integrating biomarkers still a challenge.

  2006cited by this paper
• Reporting recommendations for tumor marker prognostic studies (remark).

  2006cited by this paper
• Surrogate endpoints: wishful thinking or reality?

  2006cited by this paper
• REporting recommendations for tumor MARKer prognostic studies (REMARK)

  2005cited by this paper
• Identification of clinically useful cancer prognostic factors: what are we missing?

  2005cited by this paper
• Outcome prediction and the future of the TNM staging system.

  2004influential reference
• Rules of evidence for cancer molecular-marker discovery and validation

  2004cited by this paper
• Cancer. Developing molecular biomarkers for cancer.

  2003cited by this paper
• Developing Molecular Biomarkers for Cancer

  2003cited by this paper
• The power of prediction

  2000cited by this paper
• Integrating Multiple Clinical Tests to Increase Predictive Power

  1998cited by this paper
• Predicting response to adjuvant and radiation therapy in patients with early stage breast carcinoma

  1998cited by this paper
• Specimen banks for cancer prognostic factor research.

  1998cited by this paper
• Specimen banks for cancer prognostic factor research.

  1998cited by this paper
• Histologic grade as a prognostic factor in breast carcinoma.

  1997cited by this paper
• Surrogate End Points in Clinical Trials: Are We Being Misled?

  1996cited by this paper
• Signal Detection Theory and ROC Analysis in Psychology and Diagnostics: Collected Papers

  1996cited by this paper
• Learning from Data: Artificial Intelligence and Statistics V

  1996cited by this paper
• Statistical Analysis of Complex Systems in Biomedicine

  1995cited by this paper
• Statistical aspects of prognostic factor studies in oncology.

  1994cited by this paper
• Increasing the power of surrogate endpoint biomarkers: the aggregation of predictive factors.

  1994cited by this paper
• Increasing the power of surrogate endpoint biomarkers: the aggregation of predictive factors.

  1994cited by this paper
• Erratum: “Evaluating the Potential Usefulness of New Prognostic and Predictive Indicators in Node-Negative Breast Cancer Patients,”

  1993cited by this paper
• Criteria for prognostic factors and for an enhanced prognostic system

  1993cited by this paper
• Evaluating the potential usefulness of new prognostic and predictive indicators in node-negative breast cancer patients.

  1993cited by this paper
• Breast cancer prognostic factors: evaluation guidelines.

  1991cited by this paper
• Surrogate endpoints in clinical trials: definition and operational criteria.

  1989cited by this paper
• Regression models for prognostic prediction: advantages, problems, and suggested solutions.

  1985cited by this paper
• Evaluating the yield of medical tests.

  1982cited by this paper
• The meaning and use of the area under a receiver operating characteristic (ROC) curve.

  1982cited by this paper
• The area above the ordinal dominance graph and the area below the receiver operating characteristic graph

  1975cited by this paper
• Breast carcinoma.

  1975cited by this paper
• A new asymmetric measure of association for ordinal variables.

  1962cited by this paper

• Production of a risk mitigation matrix and four-grade threshold scale using Cox Regression to predict osteoarthritis development

  2026cites this paper
• Epigenetic markers of ageing and cancer risk.

  2026cites this paper
• Advancing Early Detection of Osteoarthritis Through Biomarker Profiling and Predictive Modelling: A Review

  2025cites this paper
• Clinicopathological Significance of Pluripotent Factors in Sinonasal Intestinal-Type Adenocarcinoma

  2025cites this paper
• Exploring the complex relationship between metabolomics and breast cancer early detection (Review)

  2025cites this paper
• Functional ambulation recovery in MCA stroke survivors: Predictive role of cognitive function and extremely low alanine aminotransferase levels: A retrospective observational study

  2025cites this paper
• Transformative Role of Artificial Intelligence in Drug Discovery and Translational Medicine: Innovations, Challenges, and Future Prospects

  2025cites this paper
• Biomarkers in Psoriasis and Psoriatic Arthritis: Where Are We Now?

  2024cites this paper
• Conceptual basis for the development of guidance for the use of biomarkers of effect in regulatory risk assessment of chemicals

  2024cites this paper
• The biomarkers ATLAS: An audit on 1100 non-small cell lung cancer from an Italian knowledge-based database.

  2024cites this paper
• In silico prediction of differentially expressed genes and functionally grouped networks in patients with inflamed pulp for screening pulpitis biomarkers

  2024cites this paper
• Optical coherence tomography as a potential surrogate marker of dopaminergic modulation across the life span.

  2024cites this paper
• The cost-effectiveness of including liquid biopsy into molecular profiling strategies for newly diagnosed advanced non-squamous non-small cell lung cancer in an Asian population.

  2024cites this paper
• Severe Acute Bronchial Asthma with Sepsis: Determining the Status of Biomarkers in the Diagnosis of the Disease

  2023cites this paper
• Copeptin: a novel prognostic biomarker in trauma: a review article

  2023influential citation
• Imaging and monitoring of granzyme B in the immune response.

  2023cites this paper
• Tumor Markers and Their Prognostic Value in Sinonasal ITAC/Non-ITAC

  2023cites this paper
• Capillary electrophoresis-mass spectrometry for intact protein analysis: Pharmaceutical and biomedical applications (2018-March 2023).

  2023cites this paper
• Plasma bioactive adrenomedullin predicts outcome after acute stroke in early rehabilitation

  2023cites this paper
• Preventable risk factors for type 2 diabetes can be detected using noninvasive spontaneous electroretinogram signals

  2023cites this paper
• Identifying predictive biomarkers of apatinib in third-line treatment of advanced colorectal cancer through comprehensive genomic profiling

  2022cites this paper
• Use of MS-GUIDE for identification of protein biomarkers for risk stratification of patients with prostate cancer

  2022cites this paper
• Gleason 6 prostate cancer: That which cannot be named

  2022cites this paper
• Mass Spectrometry-Based Proteomics of Human Milk to Identify Differentially Expressed Proteins in Women with Breast Cancer versus Controls

  2022cites this paper
• Concordance of Genomic Profiles in Matched Tissue and Plasma Samples From Chinese Patients With Lung Cancer

  2022cites this paper
• Severe testing with high-dimensional omics data for enhancing biomedical scientific discovery

  2022cites this paper
• Complete response to sotorasib as neoadjuvant treatment in patient with locally advanced primary pulmonary sarcoma harboring KRAS mutation: a case report

  2022cites this paper
• Rational Approach to Finding Genes Encoding Molecular Biomarkers: Focus on Breast Cancer

  2022cites this paper
• Lipopolysaccharide-induced interferon response networks at birth are predictive of severe viral lower respiratory infections in the first year of life

  2022cites this paper
• Melanoma overdiagnosis: why it matters and what can be done about it

  2022cites this paper
• Predicting the outcome of psoriasis treatment

  2022cites this paper
• Spontaneous electroretinogram signals to screen people with early risk factors for diabetic retinopathy

  2022cites this paper
• It Takes Two to Tango: Potential Prognostic Impact of Circulating TGF-Beta and PD-L1 in Pancreatic Cancer

  2022cites this paper
• The Value of FET PET/CT in Recurrent Glioma with a Different IDH Mutation Status: The Relationship between Imaging and Molecular Biomarkers

  2022cites this paper
• The impact of methodological choices when developing predictive models using urinary metabolite data

  2022cites this paper
• Thyrotropin suppression therapy using levothyroxine does not negatively affect breast cancer prognosis.

  2022cites this paper
• 4H12, a Murine Monoclonal Antibody Directed against Myosin Heavy Chain-9 Expressed on Acinar Cell Carcinoma of Pancreas with Potential Therapeutic Application

  2021cites this paper
• A Practical Guide to Modeling and Conducting a Cost-Effectiveness Analysis of Companion Biomarker Tests for Targeted Therapies Using R: Tutorial Paper

  2021cites this paper
• Immunohistochemical investigation of cytokine expression levels as biomarkers in transrectal ultrasound-guided needle biopsy specimens of prostate adenocarcinoma.

  2021cites this paper
• Landscape condition influences energetics, reproduction, and stress biomarkers in grizzly bears

  2021cites this paper
• Next generation sequencing in cytology

  2021cites this paper
• Initial independent validation of a genomic heart failure survival prediction algorithm

  2021cites this paper
• Robust Data Integration Method for Classification of Biomedical Data

  2021cites this paper
• Factor XII Concentrations and Risk of Intracerebral Haemorrhage. A Prospective Case-Referent Study.

  2021cites this paper
• Next Generation Sequencing in Cytopathology: Focus on Non-Small Cell Lung Cancer

  2021cites this paper
• Ki-67 as a Prognostic Biomarker in Invasive Breast Cancer

  2021cites this paper
• The promise of artificial neural networks, EEG, and MRI for Alzheimer's disease.

  2020cites this paper
• A method to study protein biomarkers in saliva using an automated capillary nano-immunoassay platform (Wes™).

  2020cites this paper
• MicroRNA‐based risk scoring system to identify early‐stage oral squamous cell carcinoma patients at high‐risk for cancer‐specific mortality

  2020cites this paper
• Inflammatory and Fibrogenic Factors in Proliferative Vitreoretinopathy Development

  2020cites this paper
• Pathway to biomarker discovery in psoriatic arthritis

  2020influential citation
• Survival of Patients with First and Metachronous Second Primary Breast Cancer or Lung Cancer Malignancy: Comparisons Using the SEER Database

  2020cites this paper
• Emerging biomarkers in urothelial carcinoma: Challenges and opportunities

  2020cites this paper
• The acute respiratory distress syndrome biomarker pipeline: crippling gaps between discovery and clinical utility

  2020cites this paper
• Development and validation of protein biomarkers of health in grizzly bears

  2020cites this paper
• A 10-gene signature as a predictor of biochemical recurrence after radical prostatectomy in patients with prostate cancer and a Gleason score ≥7

  2020cites this paper
• Data Integration Strategy for Robust Classification of Biomedical Data

  2020cites this paper
• Age-Associated Salivary MicroRNA Biomarkers for Oculopharyngeal Muscular Dystrophy

  2020cites this paper
• Host-Based Prognostic Biomarkers to Improve Risk Stratification and Outcome of Febrile Children in Low- and Middle-Income Countries

  2020cites this paper
• Multiplexed cytokine detection using electrochemical point-of-care sensing device towards rapid sepsis endotyping

  2020cites this paper
• Circular RNAs and Their Linear Transcripts as Diagnostic and Prognostic Tissue Biomarkers in Prostate Cancer after Prostatectomy in Combination with Clinicopathological Factors

  2020cites this paper
• Analysis of Cross-Association between mRNA Expression and RNAi Efficacy for Predictive Target Discovery in Colon Cancers

  2020cites this paper
• AMYLOID ANGIOPATHY IN HEREDITARY GELSOLIN AMYLOIDOSIS

  2020cites this paper
• Long noncoding RNA SNHG12 is a potential diagnostic and prognostic biomarker in various tumors

  2020cites this paper
• Circulating tumor DNA as an early cancer detection tool.

  2019cites this paper
• Are innovation and new technologies in precision medicine paving a new era in patients centric care?

  2019cites this paper
• A Novel Predictor Tool of Biochemical Recurrence after Radical Prostatectomy Based on a Five-MicroRNA Tissue Signature

  2019cites this paper
• A Multi-Cohort and Multi-Omics Meta-Analysis Framework to Identify Network-Based Gene Signatures

  2019cites this paper
• Osteopontin in Vascular Disease: Friend or Foe?

  2019cites this paper
• Is the Patient Cured?

  2019cites this paper
• Knowledge discovery with Bayesian Rule Learning for actionable biomedicine

  2019cites this paper
• The Utilization of Biospecimens: Impact of the Choice of Biobanking Model

  2019influential citation
• Immunoglobulin J chain as a non-invasive indicator of pregnancy in the cheetah (Acinonyx jubatus)

  2019cites this paper
• Recent developments in affinity-based selection of aptamers for binding disease-related protein targets

  2019cites this paper
• Interpretable deep neural network for cancer survival analysis by integrating genomic and clinical data

  2019cites this paper
• Identification of Candidate Biomarkers for Transplant Rejection from Transcriptome Data: A Systematic Review

  2019cites this paper
• Breast cancer prognosis is better in patients who develop subsequent metachronous thyroid cancer

  2019cites this paper
• Correction to: Limited utility of tissue micro-arrays in detecting intra-tumoral heterogeneity in stem cell characteristics and tumor progression markers in breast cancer

  2018cites this paper
• The search for biomarkers in the critically ill: a cautionary tale.

  2018cites this paper
• Limited utility of tissue micro-arrays in detecting intra-tumoral heterogeneity in stem cell characteristics and tumor progression markers in breast cancer

  2018cites this paper
• Patient-Reported Outcomes in Patients with Chronic Kidney Disease and Kidney Transplant—Part 1

  2018cites this paper
• Interpretable and accurate prediction models for metagenomics data

  2018cites this paper
• Cox-PASNet: Pathway-based Sparse Deep Neural Network for Survival Analysis

  2018cites this paper
• BRAF mutation in papillary thyroid cancer—Prevalence and clinical correlation in a South‐East Asian cohort

  2018cites this paper
• miR-9-5p in Nephrectomy Specimens is a Potential Predictor of Primary Resistance to First-Line Treatment with Tyrosine Kinase Inhibitors in Patients with Metastatic Renal Cell Carcinoma

  2018cites this paper
• Emerging biomarkers and targeted therapies in urothelial carcinoma.

  2018cites this paper
• A large-scale and robust dynamic MRM study of colorectal cancer biomarkers.

  2018cites this paper
• Biomarkers of oxidative stress in pregnancy complications.

  2017cites this paper
• Biomarkers in Veterinary Medicine.

  2017cites this paper
• Independent imaging biomarkers do not exist

  2017cites this paper
• Nueva generación de biomarcadores epigenéticos y transcriptómicos en el cáncer de tiroides bien diferenciado

  2017cites this paper
• Cancer biomarker sensing using packaged plasmonic optical fiber gratings: Towards in vivo diagnosis.

  2017cites this paper
• Making Meaningful Clinical Use of Biomarkers

  2017cites this paper
• Overall Survival vs Disease-Specific Survival.

  2017cites this paper
• Plasma levels of hepatocyte growth factor and placental growth factor predict mortality in a general population: a prospective cohort study

  2017cites this paper
• Tissue-Based MicroRNAs as Predictors of Biochemical Recurrence after Radical Prostatectomy: What Can We Learn from Past Studies?

  2017cites this paper
• Non-invasive identification of protein biomarkers for early pregnancy diagnosis in the cheetah (Acinonyx jubatus)

  2017cites this paper
• miR‐199a‐3p and miR‐214‐3p improve the overall survival prediction of muscle‐invasive bladder cancer patients after radical cystectomy

  2017cites this paper
• Assessment of IL-28: rs12979860 and rs8099917 Polymorphisms in a Cohort of Cuban Chronic HCV Genotype 1b Patients.

  2017cites this paper