LEADER 03928nam 2200673 a 450 001 9910960256203321 005 20251017110112.0 010 $a9786612976056 010 $a9780309187008 010 $a0309187001 010 $a9781282976054 010 $a1282976052 010 $a9780309163255 010 $a0309163250 035 $a(CKB)2550000000032049 035 $a(OCoLC)707927323 035 $a(CaPaEBR)ebrary10443278 035 $a(SSID)ssj0000540006 035 $a(PQKBManifestationID)11385680 035 $a(PQKBTitleCode)TC0000540006 035 $a(PQKBWorkID)10585251 035 $a(PQKB)11286098 035 $a(MiAaPQ)EBC3378736 035 $a(Au-PeEL)EBL3378736 035 $a(CaPaEBR)ebr10443278 035 $a(CaONFJC)MIL297605 035 $a(OCoLC)923283031 035 $a(Perlego)4739008 035 $a(DNLM)1638949 035 $a(EXLCZ)992550000000032049 100 $a20110215d2011 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aPerspectives on biomarker and surrogate endpoint evaluation $ediscussion forum summary /$fAlison Mack, Erin Balogh, and Christine M. Micheel ; Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$d2011 215 $a1 online resource (139 p.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 08$a9780309163248 311 08$a0309163242 320 $aIncludes bibliographical references (p. 99-102). 327 $aIntroduction -- 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. 330 $aIn 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.--$cSource other than Library of Congress. 606 $aBiochemical markers 615 0$aBiochemical markers. 700 $aMack$b Alison$01085987 701 $aBalogh$b Erin$01089066 701 $aMicheel$b Christine$01808125 712 02$aInstitute of Medicine (U.S.).$bCommittee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910960256203321 996 $aPerspectives on biomarker and surrogate endpoint evaluation$94367767 997 $aUNINA