Perspectives On Biomarker And Surrogate Endpoint Evaluation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309187001
Total Pages : 141 pages
Book Rating : 4.08/5 ( download)

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Download or read book Perspectives on Biomarker and Surrogate Endpoint Evaluation written by Institute of Medicine and published by National Academies Press. This book was released on 2011-01-12 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309157277
Total Pages : 335 pages
Book Rating : 4.78/5 ( download)

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Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Author : Tomasz Burzykowski
Publisher : Springer Science & Business Media
ISBN 13 : 0387270809
Total Pages : 417 pages
Book Rating : 4.07/5 ( download)

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Download or read book The Evaluation of Surrogate Endpoints written by Tomasz Burzykowski and published by Springer Science & Business Media. This book was released on 2005-11-24 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.

Author : Committee on Qualifications of Biomarkers and Surrogate Endpoints in Chronic Disease
Publisher :
ISBN 13 : 9780309384537
Total Pages : 334 pages
Book Rating : 4.32/5 ( download)

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Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Committee on Qualifications of Biomarkers and Surrogate Endpoints in Chronic Disease and published by . This book was released on 2010-06-25 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309672988
Total Pages : 127 pages
Book Rating : 4.86/5 ( download)

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Download or read book Exploring Novel Clinical Trial Designs for Gene-Based Therapies written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-08-27 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.

Author : Svetlana Dambinova
Publisher : Royal Society of Chemistry
ISBN 13 : 1849733899
Total Pages : 247 pages
Book Rating : 4.92/5 ( download)

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Download or read book Biomarkers for Traumatic Brain Injury written by Svetlana Dambinova and published by Royal Society of Chemistry. This book was released on 2012 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to injuries sustained in sports and in combat, interest in traumatic brain injury (TBI) has never been greater. This book will fulfill a gap in understanding of what is occurring in the brain following injury that can subsequently be detected in biological fluids and imaging.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309462592
Total Pages : 335 pages
Book Rating : 4.94/5 ( download)

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Download or read book Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-11-21 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1938 and 1941, nutrient intake recommendations have been issued to the public in Canada and the United States, respectively. Currently defined as the Dietary Reference Intakes (DRIs), these values are a set of standards established by consensus committees under the National Academies of Sciences, Engineering, and Medicine and used for planning and assessing diets of apparently healthy individuals and groups. In 2015, a multidisciplinary working group sponsored by the Canadian and U.S. government DRI steering committees convened to identify key scientific challenges encountered in the use of chronic disease endpoints to establish DRI values. Their report, Options for Basing Dietary Reference Intakes (DRIs) on Chronic Disease: Report from a Joint US-/Canadian-Sponsored Working Group, outlined and proposed ways to address conceptual and methodological challenges related to the work of future DRI Committees. This report assesses the options presented in the previous report and determines guiding principles for including chronic disease endpoints for food substances that will be used by future National Academies committees in establishing DRIs.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309224187
Total Pages : 354 pages
Book Rating : 4.85/5 ( download)

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Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Author : Péter Horvatovich
Publisher : Royal Society of Chemistry
ISBN 13 : 1849734224
Total Pages : 385 pages
Book Rating : 4.26/5 ( download)

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Download or read book Comprehensive Biomarker Discovery and Validation for Clinical Application written by Péter Horvatovich and published by Royal Society of Chemistry. This book was released on 2013 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers proteomics biomarker discovery and validation procedures from the clinical perspective.

Author : Jaime Marcelo Altcheh
Publisher : Springer Nature
ISBN 13 : 3030000540
Total Pages : 356 pages
Book Rating : 4.47/5 ( download)

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Download or read book Chagas Disease written by Jaime Marcelo Altcheh and published by Springer Nature. This book was released on 2019-09-09 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chagas disease is a potentially life threatening condition that was historically mainly endemic to Latin America. Over the last decade, however, the disease has spread to and is increasingly prevalent in other continents such as North America and Europe, with an estimated 7 million people infected worldwide. It is primarily transmitted by insect vectors that carry the parasite Trypanosoma cruzi, the disease agent. In areas where there is vector control and in non-endemic countries, it is mainly transmitted via congenital infection. Cardiac and gastrointestinal complications are common in untreated individuals. This book offers a comprehensive overview of Chagas disease, including its vectorial and congenital transmission, and molecular diagnosis, which is essential for screening, and developing and providing timely, effective anti-trypanosomal treatment. Written by experts working with infected patients on a daily basis, it discusses the pathogenesis of congenital, cardiac, gastrointestinal and oral Chagas disease, as well as its treatment and the pharmacological aspects of drug development in this area. Chapter "Chagas Disease Treatment Efficacy Biomarkers: Myths and Realities" is available open access under a via link.springer.com.