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Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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Acronyms

ACCORD Action to Control Cardiovascular Risk in Diabetes

ACE inhibitor angiotensin-converting enzyme inhibitor

ADA American Dietetic Association

APOE apolipoprotein E

CAST Cardiac Arrhythmia Suppression Trial

CBER Center for Biologics Evaluation and Research

CD4 cells CD4+ T-lymphocytes

CDC Centers for Disease Control and Prevention

CDER Center for Drug Evaluation and Research

CDRH Center for Devices and Radiological Health

CEA carcinoembryonic antigen

CFSAN Center for Food Safety and Applied Nutrition

CHD coronary heart disease

CLIA Clinical Laboratory Improvement Amendments

CMS Centers for Medicare & Medicaid Services

COAG Clarification of Optimal Coagulation through Genetics

COPD chronic obstructive pulmonary disease

CRN Council for Responsible Nutrition

CRP C-reactive protein

CSPI Center for Science in the Public Interest

CVD cardiovascular disease

Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
×

DDT drug development tools

DHA docosahexaenoic acid

EMEA European Medicines Agency

ESA erythropoiesis-stimulating agent

FAA Federal Aviation Administration

FDA Food and Drug Administration

FDAAA Food and Drug Administration Amendments Act

GAO Government Accountability Office

GI gastrointestinal

GMA Grocery Manufacturers Association

HDL high-density lipoprotein

HDL-C high-density lipoprotein cholesterol

HER2 human epidermal growth factor receptor 2

HHS Department of Health and Human Services

HIV human immunodeficiency virus

HRT hormone replacement therapy

IOM Institute of Medicine

IVD in vitro diagnostic

LDL low-density lipoprotein

LDL-C low-density lipoprotein cholesterol

MI myocardial infarction

MRI magnetic resonance imaging

NCI National Cancer Institute

NHANES National Health and Nutrition Examination Survey

NHLBI National Heart, Lung, and Blood Institute

NIH National Institutes of Health

NLEA Nutrition, Labeling, and Education Act

ODS Office of Dietary Supplements

PCI percutaneous coronary intervention

PET positron emission tomography

PML progressive multifocal leukoencephalopathy

PRO patient-reported outcomes

PSA prostate-specific antigen

Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
×

PSTC Predictive Safety Testing Consortium

RT-PCR reverse-transcriptase polymerase chain reaction

SABRe Systems Approach to Biomarker Research in Cardiovascular Disease

SPECT single photon emission computed tomography

TLR target lesion revascularization

TSH thyroid-stimulating hormone

USDA United States Department of Agriculture

VRE vancomycin-resistant enterococci

Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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Page 104
Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
×
Page 105
Suggested Citation:"Acronyms." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary Get This Book
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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.

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