Literature DB >> 33545385

Biomarker Discovery and Validation: Statistical Considerations.

Fang-Shu Ou1, Stefan Michiels2, Yu Shyr3, Alex A Adjei4, Ann L Oberg5.   

Abstract

Biomarkers have various applications including disease detection, diagnosis, prognosis, prediction of response to intervention, and disease monitoring. In this era of precision medicine, having validated biomarkers to inform clinical decision making is more important than ever. In this article, we discuss best the practices and potential issues in biomarker discovery and validation. We encourage team science partnerships to bring cutting-edge discovery from bench to bedside, leading to improved patient care and outcomes.
Copyright © 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Biomarker; Clinical trial; Confirmation analysis; Exploratory analysis

Mesh:

Substances:

Year:  2021        PMID: 33545385      PMCID: PMC8012218          DOI: 10.1016/j.jtho.2021.01.1616

Source DB:  PubMed          Journal:  J Thorac Oncol        ISSN: 1556-0864            Impact factor:   15.609


  25 in total

Review 1.  Phases of biomarker development for early detection of cancer.

Authors:  M S Pepe; R Etzioni; Z Feng; J D Potter; M L Thompson; M Thornquist; M Winget; Y Yasui
Journal:  J Natl Cancer Inst       Date:  2001-07-18       Impact factor: 13.506

2.  Refining Prognosis in Lung Cancer: A Report on the Quality and Relevance of Clinical Prognostic Tools.

Authors:  Alyson L Mahar; Carolyn Compton; Lisa M McShane; Susan Halabi; Hisao Asamura; Ramon Rami-Porta; Patti A Groome
Journal:  J Thorac Oncol       Date:  2015-11       Impact factor: 15.609

3.  Use of archived specimens in evaluation of prognostic and predictive biomarkers.

Authors:  Richard M Simon; Soonmyung Paik; Daniel F Hayes
Journal:  J Natl Cancer Inst       Date:  2009-10-08       Impact factor: 13.506

4.  Clinical utility of a plasma-based miRNA signature classifier within computed tomography lung cancer screening: a correlative MILD trial study.

Authors:  Gabriella Sozzi; Mattia Boeri; Marta Rossi; Carla Verri; Paola Suatoni; Francesca Bravi; Luca Roz; Davide Conte; Michela Grassi; Nicola Sverzellati; Alfonso Marchiano; Eva Negri; Carlo La Vecchia; Ugo Pastorino
Journal:  J Clin Oncol       Date:  2014-01-13       Impact factor: 44.544

5.  2020 ASCO Virtual Annual Meeting.

Authors:  David Collingridge
Journal:  Lancet Oncol       Date:  2020-06-05       Impact factor: 41.316

Review 6.  Biomarker studies: a call for a comprehensive biomarker study registry.

Authors:  Fabrice Andre; Lisa M McShane; Stefan Michiels; David F Ransohoff; Douglas G Altman; Jorge S Reis-Filho; Daniel F Hayes; Lajos Pusztai
Journal:  Nat Rev Clin Oncol       Date:  2011-03       Impact factor: 66.675

7.  Blocking and randomization to improve molecular biomarker discovery.

Authors:  Li-Xuan Qin; Qin Zhou; Faina Bogomolniy; Liliana Villafania; Narciso Olvera; Magali Cavatore; Jaya M Satagopan; Colin B Begg; Douglas A Levine
Journal:  Clin Cancer Res       Date:  2014-05-01       Impact factor: 12.531

8.  Discussion of Trial Designs for Biomarker Identification and Validation Through the Use of Case Studies.

Authors:  Fang-Shu Ou; Ming-Wen An; Amy S Ruppert; Sumithra J Mandrekar
Journal:  JCO Precis Oncol       Date:  2019-10-24

9.  Different prognostic impact of STK11 mutations in non-squamous non-small-cell lung cancer.

Authors:  Nicolas Pécuchet; Pierre Laurent-Puig; Audrey Mansuet-Lupo; Antoine Legras; Marco Alifano; Karine Pallier; Audrey Didelot; Laure Gibault; Claire Danel; Pierre-Alexandre Just; Marc Riquet; Françoise Le Pimpec-Barthes; Diane Damotte; Elisabeth Fabre; Hélène Blons
Journal:  Oncotarget       Date:  2017-04-04

Review 10.  Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease.

Authors:  Michael M Boyiadzis; John M Kirkwood; John L Marshall; Colin C Pritchard; Nilofer S Azad; James L Gulley
Journal:  J Immunother Cancer       Date:  2018-05-14       Impact factor: 13.751

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  11 in total

1.  Considerations of biomarker application for cancer continuum in the era of precision medicine.

Authors:  Rayjean J Hung; Elham Khodayari Moez; Shana J Kim; Sanjeev Budhathoki; Jennifer D Brooks
Journal:  Curr Epidemiol Rep       Date:  2022-07-09

2.  Can neural markers be used for fibromyalgia clinical management?

Authors:  Luis Castelo-Branco; Alejandra Cardenas-Rojas; Kevin Pacheco-Barrios; Paulo E P Teixeira; Paola Gonzalez-Mego; Karen Vasquez-Avila; Pablo Costa Cortez; Anna Marduy; Ingrid Rebello-Sanchez; Joao Parente; Sammer Marzouk; Felipe Fregni
Journal:  Princ Pract Clin Res       Date:  2022-04-24

3.  A Novel Hybrid Deep Learning Model for Metastatic Cancer Detection.

Authors:  Shahab Ahmad; Tahir Ullah; Ijaz Ahmad; Abdulkarem Al-Sharabi; Kalim Ullah; Rehan Ali Khan; Saim Rasheed; Inam Ullah; Md Nasir Uddin; Md Sadek Ali
Journal:  Comput Intell Neurosci       Date:  2022-06-24

4.  The Spatial Landscape of Progression and Immunoediting in Primary Melanoma at Single-Cell Resolution.

Authors:  Ajit J Nirmal; Zoltan Maliga; Tuulia Vallius; Sandro Santagata; Peter K Sorger; Brian Quattrochi; Alyce A Chen; Connor A Jacobson; Roxanne J Pelletier; Clarence Yapp; Raquel Arias-Camison; Yu-An Chen; Christine G Lian; George F Murphy
Journal:  Cancer Discov       Date:  2022-06-02       Impact factor: 38.272

5.  Measurement of circulating CD21-CD27- B lymphocytes in SLE patients is associated with disease activity independently of conventional serological biomarkers.

Authors:  Alice Horisberger; Morgane Humbel; Natalia Fluder; Florence Bellanger; Craig Fenwick; Camillo Ribi; Denis Comte
Journal:  Sci Rep       Date:  2022-06-02       Impact factor: 4.996

6.  Comprehensive Genomic Profiling of Circulating Tumor DNA in Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of a Real-World Healthcare Claims Database.

Authors:  Yoshiaki Nakamura; Steven Olsen; Nicole Zhang; Jiemin Liao; Takayuki Yoshino
Journal:  Curr Oncol       Date:  2022-05-09       Impact factor: 3.109

Review 7.  A scoping review of autoantibodies as biomarkers for canine autoimmune disease.

Authors:  Amy E Treeful; Emily L Coffey; Steven G Friedenberg
Journal:  J Vet Intern Med       Date:  2022-02-22       Impact factor: 3.333

Review 8.  Molecular Biomarkers in Cancer.

Authors:  Virinder Kaur Sarhadi; Gemma Armengol
Journal:  Biomolecules       Date:  2022-07-23

9.  Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC).

Authors:  Michael B Atkins; Hamzah Abu-Sbeih; Paolo A Ascierto; Michael R Bishop; Daniel S Chen; Madhav Dhodapkar; Leisha A Emens; Marc S Ernstoff; Robert L Ferris; Tim F Greten; James L Gulley; Roy S Herbst; Rachel W Humphrey; James Larkin; Kim A Margolin; Luca Mazzarella; Suresh S Ramalingam; Meredith M Regan; Brian I Rini; Mario Sznol
Journal:  J Immunother Cancer       Date:  2022-09       Impact factor: 12.469

10.  Emerging New Biomarkers for Cardiovascular Disease.

Authors:  Luc Rochette
Journal:  Int J Mol Sci       Date:  2022-03-18       Impact factor: 5.923

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