The Evaluation Of Surrogate Endpoints
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The Evaluation Of Surrogate Endpoints
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Author : Tomasz Burzykowski
language : en
Publisher: Springer Science & Business Media
Release Date : 2005-11-24
The Evaluation Of Surrogate Endpoints written by Tomasz Burzykowski and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-24 with Medical categories.
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.
Evaluation Of Biomarkers And Surrogate Endpoints In Chronic Disease
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-07-25
Evaluation Of Biomarkers And Surrogate Endpoints In Chronic Disease written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-25 with Medical categories.
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.
The Evaluation Of Surrogate Endpoints
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Author : Geert Molenberghs
language : en
Publisher: Springer Science & Business Media
Release Date : 2005-02-28
The Evaluation Of Surrogate Endpoints written by Geert Molenberghs and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-02-28 with Mathematics categories.
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.
Handbook Of Meta Analysis
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Author : Christopher H. Schmid
language : en
Publisher: CRC Press
Release Date : 2020-09-07
Handbook Of Meta Analysis written by Christopher H. Schmid and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-09-07 with Mathematics categories.
Meta-analysis is the application of statistics to combine results from multiple studies and draw appropriate inferences. Its use and importance have exploded over the last 25 years as the need for a robust evidence base has become clear in many scientific areas, including medicine and health, social sciences, education, psychology, ecology, and economics. Recent years have seen an explosion of methods for handling complexities in meta-analysis, including explained and unexplained heterogeneity between studies, publication bias, and sparse data. At the same time, meta-analysis has been extended beyond simple two-group comparisons of continuous and binary outcomes to comparing and ranking the outcomes from multiple groups, to complex observational studies, to assessing heterogeneity of effects, and to survival and multivariate outcomes. Many of these methods are statistically complex and are tailored to specific types of data. Key features Rigorous coverage of the full range of current statistical methodology used in meta-analysis Comprehensive, coherent, and unified overview of the statistical foundations behind meta-analysis Detailed description of the primary methods for both univariate and multivariate data Computer code to reproduce examples in chapters Thorough review of the literature with thousands of references Applications to specific types of biomedical and social science data Supplementary website with code, data, sample chapters, and errata This book is for a broad audience of graduate students, researchers, and practitioners interested in the theory and application of statistical methods for meta-analysis. It is written at the level of graduate courses in statistics, but will be of interest to and readable for quantitative scientists from a range of disciplines. The book can be used as a graduate level textbook, as a general reference for methods, or as an introduction to specialized topics using state-of-the art methods.
Exploring Novel Clinical Trial Designs For Gene Based Therapies
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-08-27
Exploring Novel Clinical Trial Designs For Gene Based Therapies written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-08-27 with Medical categories.
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.
Applied Surrogate Endpoint Evaluation Methods With Sas And R
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Author : Ariel Alonso
language : en
Publisher: CRC Press
Release Date : 2016-11-30
Applied Surrogate Endpoint Evaluation Methods With Sas And R written by Ariel Alonso and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-30 with Mathematics categories.
An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.
Evolution Of Translational Omics
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-09-13
Evolution Of Translational Omics written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-13 with Science categories.
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.
The Drug Development Paradigm In Oncology
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-02-12
The Drug Development Paradigm In Oncology written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-02-12 with Medical categories.
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Perspectives On Biomarker And Surrogate Endpoint Evaluation
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-01-12
Perspectives On Biomarker And Surrogate Endpoint Evaluation written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-01-12 with Medical categories.
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.