Perspectives on biomarker and surrogate endpoint evaluation :: discussion forum summary /
In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previousl...
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| Hauptverfasser: | , , |
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| Körperschaften: | , |
| Format: | Elektronisch Tagungsbericht E-Book |
| Sprache: | English |
| Veröffentlicht: |
Washington, D.C. :
The National Academies Press,
[2011]
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| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations. |
| Beschreibung: | Title from PDF title page. |
| Beschreibung: | 1 online resource (1 PDF file (ix, 129 pages) :) |
| Bibliographie: | Includes bibliographical references. |
| ISBN: | 9780309163248 0309163242 9780309163255 0309163250 1282976052 9781282976054 |
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| 520 | 3 | |a In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations. | |
| 536 | |a This study was supported by Contract No. HHSF223200810020I between the National Academy of Sciences and the Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. | ||
| 588 | 0 | |a Version viewed Sept. 10, 2014. | |
| 505 | 0 | 0 | |t Introduction -- |t Committee findings and recommendations -- |t FDA perspectives -- |t National institutes of health perspectives -- |t Industry perspectives -- |t Public health, consumer, and consulting organization perspectives -- |t Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease -- |t Key themes, challenges, and opportunities -- |t Importance of the biomarker discussion forum. |
| 630 | 0 | 2 | |a Evaluation of biomarkers and surrogate endpoints in chronic disease. |
| 650 | 0 | |a Biochemical markers |x Evaluation |v Congresses. | |
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| 650 | 0 | |a Biochemical markers. |0 http://id.loc.gov/authorities/subjects/sh85014122 | |
| 650 | 0 | |a Chronic diseases. |0 http://id.loc.gov/authorities/subjects/sh85025392 | |
| 650 | 0 | |a Evidence-based medicine. |0 http://id.loc.gov/authorities/subjects/sh97007984 | |
| 650 | 1 | 2 | |a Biomarkers. |
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| 650 | 2 | 2 | |a Evidence-Based Practice |0 https://id.nlm.nih.gov/mesh/D055317 |
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| author | Mack, Alison Balogh, Erin Micheel, Christine |
| author_corporate | Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (Discussion forum) |
| author_corporate_role | aut |
| author_facet | Mack, Alison Balogh, Erin Micheel, Christine Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (Discussion forum) |
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| contents | Introduction -- Committee findings and recommendations -- FDA perspectives -- National institutes of health perspectives -- Industry perspectives -- Public health, consumer, and consulting organization perspectives -- Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease -- Key themes, challenges, and opportunities -- Importance of the biomarker discussion forum. |
| ctrlnum | (OCoLC)707927323 |
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| discipline | Medizin |
| format | Electronic Conference Proceeding eBook |
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| indexdate | 2024-10-25T16:18:01Z |
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| spelling | Mack, Alison, author. Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / Alison Mack, Erin Balogh, and Christine M. Micheel, rapporteurs ; Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Board on Health Care Services, Board on Health Sciences Policy, Food and Nutrition Board, Institute of Medicine of the National Academies. Washington, D.C. : The National Academies Press, [2011] 1 online resource (1 PDF file (ix, 129 pages) :) text txt rdacontent computer c rdamedia online resource cr rdacarrier Title from PDF title page. Includes bibliographical references. In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations. This study was supported by Contract No. HHSF223200810020I between the National Academy of Sciences and the Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Version viewed Sept. 10, 2014. Introduction -- Committee findings and recommendations -- FDA perspectives -- National institutes of health perspectives -- Industry perspectives -- Public health, consumer, and consulting organization perspectives -- Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease -- Key themes, challenges, and opportunities -- Importance of the biomarker discussion forum. Evaluation of biomarkers and surrogate endpoints in chronic disease. Biochemical markers Evaluation Congresses. Drugs United States Testing Congresses. Clinical trials Congresses. Chronic diseases Congresses. Biochemical markers. http://id.loc.gov/authorities/subjects/sh85014122 Chronic diseases. http://id.loc.gov/authorities/subjects/sh85025392 Evidence-based medicine. http://id.loc.gov/authorities/subjects/sh97007984 Biomarkers. Chronic Disease https://id.nlm.nih.gov/mesh/D002908 Evidence-Based Practice https://id.nlm.nih.gov/mesh/D055317 Evidence-Based Medicine https://id.nlm.nih.gov/mesh/D019317 Marqueurs biologiques Évaluation Congrès. Médicaments États-Unis Essais cliniques Congrès. Études cliniques Congrès. Maladies chroniques Congrès. Marqueurs biologiques. Maladies chroniques. Médecine factuelle. TECHNOLOGY & ENGINEERING Biomedical. bisacsh MEDICAL Family & General Practice. bisacsh MEDICAL Allied Health Services Medical Technology. bisacsh MEDICAL Biotechnology. bisacsh MEDICAL Lasers in Medicine. bisacsh Evidence-based medicine fast Biochemical markers fast Biochemical markers Evaluation fast Chronic diseases fast Clinical trials fast Drugs Testing fast United States fast Congress https://id.nlm.nih.gov/mesh/D016423 proceedings (reports) aat Conference papers and proceedings fast Conference papers and proceedings. lcgft http://id.loc.gov/authorities/genreForms/gf2014026068 Actes de congrès. rvmgf Balogh, Erin, author. Micheel, Christine, author. Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, author. http://id.loc.gov/authorities/names/n2010182021 Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (Discussion forum) (2010 : Washington, D.C.) http://id.loc.gov/authorities/names/n2014188419 has work: Perspectives on biomarker and surrogate endpoint evaluation (Text) https://id.oclc.org/worldcat/entity/E39PCGX67p9gDVBhWCTjmPtrmd https://id.oclc.org/worldcat/ontology/hasWork Print version: Perspectives on biomarker and surrogate endpoint evaluation. Washington, D.C. : National Academies Press, ©2011 9780309163248 (OCoLC)707494250 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=354514 Volltext CBO01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=354514 Volltext |
| spellingShingle | Mack, Alison Balogh, Erin Micheel, Christine Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / Introduction -- Committee findings and recommendations -- FDA perspectives -- National institutes of health perspectives -- Industry perspectives -- Public health, consumer, and consulting organization perspectives -- Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease -- Key themes, challenges, and opportunities -- Importance of the biomarker discussion forum. Evaluation of biomarkers and surrogate endpoints in chronic disease. Biochemical markers Evaluation Congresses. Drugs United States Testing Congresses. Clinical trials Congresses. Chronic diseases Congresses. Biochemical markers. http://id.loc.gov/authorities/subjects/sh85014122 Chronic diseases. http://id.loc.gov/authorities/subjects/sh85025392 Evidence-based medicine. http://id.loc.gov/authorities/subjects/sh97007984 Biomarkers. Chronic Disease https://id.nlm.nih.gov/mesh/D002908 Evidence-Based Practice https://id.nlm.nih.gov/mesh/D055317 Evidence-Based Medicine https://id.nlm.nih.gov/mesh/D019317 Marqueurs biologiques Évaluation Congrès. Médicaments États-Unis Essais cliniques Congrès. Études cliniques Congrès. Maladies chroniques Congrès. Marqueurs biologiques. Maladies chroniques. Médecine factuelle. TECHNOLOGY & ENGINEERING Biomedical. bisacsh MEDICAL Family & General Practice. bisacsh MEDICAL Allied Health Services Medical Technology. bisacsh MEDICAL Biotechnology. bisacsh MEDICAL Lasers in Medicine. bisacsh Evidence-based medicine fast Biochemical markers fast Biochemical markers Evaluation fast Chronic diseases fast Clinical trials fast Drugs Testing fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh85014122 http://id.loc.gov/authorities/subjects/sh85025392 http://id.loc.gov/authorities/subjects/sh97007984 https://id.nlm.nih.gov/mesh/D002908 https://id.nlm.nih.gov/mesh/D055317 https://id.nlm.nih.gov/mesh/D019317 https://id.nlm.nih.gov/mesh/D016423 http://id.loc.gov/authorities/genreForms/gf2014026068 |
| title | Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / |
| title_alt | Introduction -- Committee findings and recommendations -- FDA perspectives -- National institutes of health perspectives -- Industry perspectives -- Public health, consumer, and consulting organization perspectives -- Presentation by Thomas Fleming: biomarkers and surrogate endpoints in chronic disease -- Key themes, challenges, and opportunities -- Importance of the biomarker discussion forum. Evaluation of biomarkers and surrogate endpoints in chronic disease. |
| title_auth | Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / |
| title_exact_search | Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / |
| title_full | Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / Alison Mack, Erin Balogh, and Christine M. Micheel, rapporteurs ; Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Board on Health Care Services, Board on Health Sciences Policy, Food and Nutrition Board, Institute of Medicine of the National Academies. |
| title_fullStr | Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / Alison Mack, Erin Balogh, and Christine M. Micheel, rapporteurs ; Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Board on Health Care Services, Board on Health Sciences Policy, Food and Nutrition Board, Institute of Medicine of the National Academies. |
| title_full_unstemmed | Perspectives on biomarker and surrogate endpoint evaluation : discussion forum summary / Alison Mack, Erin Balogh, and Christine M. Micheel, rapporteurs ; Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Board on Health Care Services, Board on Health Sciences Policy, Food and Nutrition Board, Institute of Medicine of the National Academies. |
| title_short | Perspectives on biomarker and surrogate endpoint evaluation : |
| title_sort | perspectives on biomarker and surrogate endpoint evaluation discussion forum summary |
| title_sub | discussion forum summary / |
| topic | Evaluation of biomarkers and surrogate endpoints in chronic disease. Biochemical markers Evaluation Congresses. Drugs United States Testing Congresses. Clinical trials Congresses. Chronic diseases Congresses. Biochemical markers. http://id.loc.gov/authorities/subjects/sh85014122 Chronic diseases. http://id.loc.gov/authorities/subjects/sh85025392 Evidence-based medicine. http://id.loc.gov/authorities/subjects/sh97007984 Biomarkers. Chronic Disease https://id.nlm.nih.gov/mesh/D002908 Evidence-Based Practice https://id.nlm.nih.gov/mesh/D055317 Evidence-Based Medicine https://id.nlm.nih.gov/mesh/D019317 Marqueurs biologiques Évaluation Congrès. Médicaments États-Unis Essais cliniques Congrès. Études cliniques Congrès. Maladies chroniques Congrès. Marqueurs biologiques. Maladies chroniques. Médecine factuelle. TECHNOLOGY & ENGINEERING Biomedical. bisacsh MEDICAL Family & General Practice. bisacsh MEDICAL Allied Health Services Medical Technology. bisacsh MEDICAL Biotechnology. bisacsh MEDICAL Lasers in Medicine. bisacsh Evidence-based medicine fast Biochemical markers fast Biochemical markers Evaluation fast Chronic diseases fast Clinical trials fast Drugs Testing fast |
| topic_facet | Evaluation of biomarkers and surrogate endpoints in chronic disease. Biochemical markers Evaluation Congresses. Drugs United States Testing Congresses. Clinical trials Congresses. Chronic diseases Congresses. Biochemical markers. Chronic diseases. Evidence-based medicine. Biomarkers. Chronic Disease Evidence-Based Practice Evidence-Based Medicine Marqueurs biologiques Évaluation Congrès. Médicaments États-Unis Essais cliniques Congrès. Études cliniques Congrès. Maladies chroniques Congrès. Marqueurs biologiques. Maladies chroniques. Médecine factuelle. TECHNOLOGY & ENGINEERING Biomedical. MEDICAL Family & General Practice. MEDICAL Allied Health Services Medical Technology. MEDICAL Biotechnology. MEDICAL Lasers in Medicine. Evidence-based medicine Biochemical markers Biochemical markers Evaluation Chronic diseases Clinical trials Drugs Testing United States Congress proceedings (reports) Conference papers and proceedings Conference papers and proceedings. Actes de congrès. |
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