Perspectives on biomarker and surrogate endpoint evaluation: discussion forum summary
Gespeichert in:
| Beteilige Person: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | Englisch |
| Veröffentlicht: |
Washington, D.C.
The National Academies Press
[2011]
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| Schlagwörter: | |
| Links: | http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=354514 http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=354514 http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=354514 |
| Beschreibung: | Title from PDF title page. - Analysis of: Evaluation of biomarkers and surrogate endpoints in chronic disease. Washington, D.C. : National Academies Press, c2010 Description based on version viewed Sept. 10, 2014 |
| Umfang: | 1 online resource (1 PDF file (ix, 129 pages)) illustrations |
| ISBN: | 0309163242 0309163250 9780309163248 9780309163255 |
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| 500 | |a Description based on version viewed Sept. 10, 2014 | ||
| 505 | 8 | |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 | |
| 505 | 8 | 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 |
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Datensatz im Suchindex
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| contents | 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 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 (DE-599)BVBBV043034860 |
| dewey-full | 610.28 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610.28 |
| dewey-search | 610.28 |
| dewey-sort | 3610.28 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Electronic eBook |
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| spelling | Mack, Alison Verfasser aut 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)) illustrations txt rdacontent c rdamedia cr rdacarrier Title from PDF title page. - Analysis of: Evaluation of biomarkers and surrogate endpoints in chronic disease. Washington, D.C. : National Academies Press, c2010 Description based on version viewed Sept. 10, 2014 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 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 Biological Markers / Congresses Chronic Disease / Congresses Evidence-Based Practice / Congresses TECHNOLOGY & ENGINEERING / Biomedical bisacsh MEDICAL / Family & General Practice bisacsh MEDICAL / Allied Health Services / Medical Technology bisacsh MEDICAL / Biotechnology bisacsh MEDICAL / Lasers in Medicine bisacsh Biochemical markers / Evaluation fast Chronic diseases fast Clinical trials fast Drugs / Testing fast Medizin Biochemical markers Evaluation Congresses Drugs United States Testing Congresses Clinical trials Congresses Chronic diseases Congresses USA (DE-588)1071861417 Konferenzschrift gnd-content Balogh, Erin Sonstige oth Micheel, Christine Sonstige oth Institute of Medicine (U.S.) Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease Sonstige oth Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (Discussion forum) <2010, Washington, D.C.> Sonstige oth Erscheint auch als Druck-Ausgabe Perspectives on biomarker and surrogate endpoint evaluation http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=354514 Aggregator Volltext |
| spellingShingle | Mack, Alison 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 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 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 Biological Markers / Congresses Chronic Disease / Congresses Evidence-Based Practice / Congresses TECHNOLOGY & ENGINEERING / Biomedical bisacsh MEDICAL / Family & General Practice bisacsh MEDICAL / Allied Health Services / Medical Technology bisacsh MEDICAL / Biotechnology bisacsh MEDICAL / Lasers in Medicine bisacsh Biochemical markers / Evaluation fast Chronic diseases fast Clinical trials fast Drugs / Testing fast Medizin Biochemical markers Evaluation Congresses Drugs United States Testing Congresses Clinical trials Congresses Chronic diseases Congresses |
| subject_GND | (DE-588)1071861417 |
| 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 |
| 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 Biological Markers / Congresses Chronic Disease / Congresses Evidence-Based Practice / Congresses TECHNOLOGY & ENGINEERING / Biomedical bisacsh MEDICAL / Family & General Practice bisacsh MEDICAL / Allied Health Services / Medical Technology bisacsh MEDICAL / Biotechnology bisacsh MEDICAL / Lasers in Medicine bisacsh Biochemical markers / Evaluation fast Chronic diseases fast Clinical trials fast Drugs / Testing fast Medizin Biochemical markers Evaluation Congresses Drugs United States Testing Congresses Clinical trials Congresses Chronic diseases Congresses |
| topic_facet | Evaluation of biomarkers and surrogate endpoints in chronic disease Biological Markers / Congresses Chronic Disease / Congresses Evidence-Based Practice / Congresses TECHNOLOGY & ENGINEERING / Biomedical MEDICAL / Family & General Practice MEDICAL / Allied Health Services / Medical Technology MEDICAL / Biotechnology MEDICAL / Lasers in Medicine Biochemical markers / Evaluation Chronic diseases Clinical trials Drugs / Testing Medizin Biochemical markers Evaluation Congresses Drugs United States Testing Congresses Clinical trials Congresses Chronic diseases Congresses USA Konferenzschrift |
| url | http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=354514 |
| work_keys_str_mv | AT mackalison perspectivesonbiomarkerandsurrogateendpointevaluationdiscussionforumsummary AT balogherin perspectivesonbiomarkerandsurrogateendpointevaluationdiscussionforumsummary AT micheelchristine perspectivesonbiomarkerandsurrogateendpointevaluationdiscussionforumsummary AT instituteofmedicineuscommitteeonqualificationofbiomarkersandsurrogateendpointsinchronicdisease perspectivesonbiomarkerandsurrogateendpointevaluationdiscussionforumsummary AT evaluationofbiomarkersandsurrogateendpointsinchronicdiseasediscussionforum2010washingtondc perspectivesonbiomarkerandsurrogateendpointevaluationdiscussionforumsummary |