Literature DB >> 29294069

The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncology.

Daniel N Cagney1, Joohee Sul2, Raymond Y Huang3, Keith L Ligon4, Patrick Y Wen5, Brian M Alexander1.   

Abstract

In early 2016, the FDA and the National Institutes of Health (NIH) published the first version of the glossary included in the Biomarkers, EndpointS, and other Tools (BEST) resource.1 The BEST glossary was constructed to harmonize and clarify terms used in translational science and medical product development and to provide a common language used for communication by those agencies. It is considered a "living" document that will be updated in the future. This review will discuss the main biomarker and clinical outcome categories contained in the BEST glossary as they apply to neuro-oncology, as well as the overlapping and hierarchical relationships among them.

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Year:  2018        PMID： 29294069      PMCID： PMC6071649          DOI： 10.1093/neuonc/nox242

Source DB:  PubMed          Journal:  Neuro Oncol        ISSN： 1522-8517            Impact factor:   12.300


  82 in total

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Review 3.  Imaging genomics of Glioblastoma: state of the art bridge between genomics and neuroradiology.

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Review 4.  The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary.

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Journal:  Acta Neuropathol       Date:  2016-05-09       Impact factor: 17.088

5.  A multigene predictor of outcome in glioblastoma.

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Journal:  Neuro Oncol       Date:  2009-10-20       Impact factor: 12.300

6.  A randomized trial of bevacizumab for newly diagnosed glioblastoma.

Authors:  Mark R Gilbert; James J Dignam; Terri S Armstrong; Jeffrey S Wefel; Deborah T Blumenthal; Michael A Vogelbaum; Howard Colman; Arnab Chakravarti; Stephanie Pugh; Minhee Won; Robert Jeraj; Paul D Brown; Kurt A Jaeckle; David Schiff; Volker W Stieber; David G Brachman; Maria Werner-Wasik; Ivo W Tremont-Lukats; Erik P Sulman; Kenneth D Aldape; Walter J Curran; Minesh P Mehta
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Review 7.  Validation of analytic methods for biomarkers used in drug development.

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8.  Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402.

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Journal:  J Clin Oncol       Date:  2012-10-15       Impact factor: 44.544

9.  Net clinical benefit analysis of radiation therapy oncology group 0525: a phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma.

Authors:  Terri S Armstrong; Jeffrey S Wefel; Meihua Wang; Mark R Gilbert; Minhee Won; Andrew Bottomley; Tito R Mendoza; Corneel Coens; Maria Werner-Wasik; David G Brachman; Ali K Choucair; Minesh Mehta
Journal:  J Clin Oncol       Date:  2013-10-07       Impact factor: 44.544

Review 10.  Modern brain tumor imaging.

Authors:  Marc C Mabray; Ramon F Barajas; Soonmee Cha
Journal:  Brain Tumor Res Treat       Date:  2015-04-29
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Journal:  Front Immunol       Date:  2021-02-01       Impact factor: 7.561

2.  Animal Models: A Non-human Primate and Rodent Animal Model Research Platform, Natural History, and Biomarkers to Predict Clinical Outcome.

Authors:  Thomas J MacVittie; Ann M Farese; Maureen A Kane
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3.  Deciphering clinical significance of BCL11A isoforms and protein expression roles in triple-negative breast cancer subtype.

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Journal:  J Cancer Res Clin Oncol       Date:  2022-08-28       Impact factor: 4.322

Review 4.  How Nanotechnology and Biomedical Engineering Are Supporting the Identification of Predictive Biomarkers in Neuro-Oncology.

Authors:  Mario Ganau; Marco Paris; Nikolaos Syrmos; Laura Ganau; Gianfranco K I Ligarotti; Ali Moghaddamjou; Lara Prisco; Rossano Ambu; Salvatore Chibbaro
Journal:  Medicines (Basel)       Date:  2018-02-26

Review 5.  Assessing Response to Therapy for Nontuberculous Mycobacterial Lung Disease: Quo Vadis?

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6.  Identification of Pan-Cancer Prognostic Biomarkers Through Integration of Multi-Omics Data.

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Review 7.  Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities.

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Journal:  Nat Rev Neurol       Date:  2020-06-15       Impact factor: 42.937

8.  Small Extracellular Vesicles Isolated from Serum May Serve as Signal-Enhancers for the Monitoring of CNS Tumors.

Authors:  Gabriella Dobra; Matyas Bukva; Zoltan Szabo; Bella Bruszel; Maria Harmati; Edina Gyukity-Sebestyen; Adrienn Jenei; Monika Szucs; Peter Horvath; Tamas Biro; Almos Klekner; Krisztina Buzas
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Review 9.  Machine learning and glioma imaging biomarkers.

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Journal:  Clin Radiol       Date:  2019-07-29       Impact factor: 2.350

10.  Perspectives on statistical strategies for the regulatory biomarker qualification process.

Authors:  Suzanne B Hendrix; Robin Mogg; Sue Jane Wang; Aloka Chakravarty; Klaus Romero; Samuel P Dickson; John-Michael Sauer; Lisa M McShane
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