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010 a| 2011378635;

020 a| 9780309163248 (pbk.);

020 a| 0309163242 (pbk.);

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050 00 a| R853.B54b| P47 2011;

245 00 a| Perspectives on biomarker and surrogate endpoint evaluationh| [electronic resource] :b| discussion forum summary /c| 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.;

260 a| Washington, D.C. :b| National Academies Press,;

300 a| x, 129 p. :b| charts,c| 23 cm.;

500 a| Summary of a discussion forum that took place in Washington, DC on June 21-22, 2010.;

504 a| Includes bibliographical references.;

505 0 a| 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.;

506 a| Available only to authorized users.;

520 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.--c| Source other than Library of Congress.;

538 a| Mode of access: World Wide Web;

650 0 a| Biochemical markersx| Evaluation.=| ^A160152;

650 0 a| Drugsz| United Statesx| Testing.=| ^A1001107;

650 0 a| Clinical trials.=| ^A11330;

650 0 a| Chronic diseases.=| ^A332500;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Mack, Alison.=| ^A961929;

700 1 a| Balogh, Erin.=| ^A1108144;

700 1 a| Micheel, Christine.=| ^A1021842;

710 2 a| Institute of Medicine (U.S.).b| Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease.=| ^A1021245;

710 2 a| Institute of Medicine (U.S.).b| Board on Health Care Services.=| ^A881507;

710 2 a| Institute of Medicine (U.S.).b| Board on Health Sciences Policy.=| ^A846898;

710 2 a| Institute of Medicine (U.S.).b| Food and Nutrition Board.=| ^A419192;

710 2 a| National Academies Press (U.S.)=| ^A536339;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=3378736;

947 a| (OCoLC)ocn707494250;

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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.

Format	Electronic
Publication Info	Washington, D.C. : National Academies Press,
Description	x, 129 p. : charts, 23 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	Biochemical markers--Evaluation. Drugs--United States. --Testing. Clinical trials. Chronic diseases.

Other author/creator	Mack, Alison.
Other author/creator	Balogh, Erin.
Other author/creator	Micheel, Christine.
Other author/creator	Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease.
Other author/creator	Institute of Medicine (U.S.). Board on Health Care Services.
Other author/creator	Institute of Medicine (U.S.). Board on Health Sciences Policy.
Other author/creator	Institute of Medicine (U.S.). Food and Nutrition Board.
Other author/creator	National Academies Press (U.S.)
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.
Abstract	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.-- Source other than Library of Congress.
General note	Summary of a discussion forum that took place in Washington, DC on June 21-22, 2010.
Bibliography note	Includes bibliographical references.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2011378635
ISBN	9780309163248 (pbk.)
ISBN	0309163242 (pbk.)

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