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Clinical And Statistical Considerations In Personalized Medicine

Author: Claudio Carini
Publisher: CRC Press
ISBN: 1466593873
Size: 59.53 MB
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The Future of Clinical Research and Health Care: From Empirical to Precision Medicine Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease Treatment The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subsequent chapters examine the statistical considerations in applying a personalized medicine approach, including multiplicity in pharmacogenomics. The last chapter assesses the regulatory issues involved in using biomarkers. Improve Patient Care and Reduce Costs and Side Effects Despite the vast amount of literature on biomarkers, there is no comprehensive book that integrates the clinical and statistical components. This book is one of the first to incorporate both the clinical and statistical aspects of biomarkers in the personalized medicine paradigm. Covering a wide spectrum of personalized medicine-related topics, it presents state-of-the-art techniques for advancing the application of biomarkers in drug discovery and development.

Applied Statistics In Biomedicine And Clinical Trials Design

Author: Zhen Chen
Publisher: Springer
ISBN: 3319126946
Size: 74.87 MB
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This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.

Statistical Applications From Clinical Trials And Personalized Medicine To Finance And Business Analytics

Author: Jianchang Lin
Publisher: Springer
ISBN: 3319425684
Size: 60.34 MB
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The papers in this volume represent a broad, applied swath of advanced contributions to the 2015 ICSA/Graybill Applied Statistics Symposium of the International Chinese Statistical Association, held at Colorado State University in Fort Collins. The contributions cover topics that range from statistical applications in business and finance to applications in clinical trials and biomarker analysis. Each papers was peer-reviewed by at least two referees and also by an editor. The conference was attended by over 400 participants from academia, industry, and government agencies around the world, including from North America, Asia, and Europe.

Cancer Clinical Trials

Author: Stephen L. George
Publisher: CRC Press
ISBN: 1498706908
Size: 24.20 MB
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Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Statistical Approaches In Oncology Clinical Development

Author: Satrajit Roychoudhury
Publisher: CRC Press
ISBN: 9781498772693
Size: 66.34 MB
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Statistical Challenges in Oncology Clinical Development presents an overview of statistical considerations in oncology clinical trials, including both early and late phase of development. It illustrates how the novel statistical methods can enrich the design and analysis of modern oncology trials. The book covers wide spectrum of statistical methodology with real life examples. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The authors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis and quality of life data analysis. The final part discusses current regulatory perspective and challenges. Statisticians, key opinion leaders and strategy makers involved in oncology trials will find this book useful. This book provides researchers a solid overview of available methodologies. Along with describing the necessary statistical theory, the authors illustrate the practical application of the techniques. The authors include many relevant real life examples from pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. Features: It covers a wide spectrum of topics related to real life statistical challenges in oncology clinical trials. This provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real-life applications. Authors are eminent members from pharmaceutical industry, FDA and academia who have several years of hands in experience in clinical trial.

Holland Frei Cancer Medicine

Author: Robert C. Bast, Jr.
Publisher: John Wiley & Sons
ISBN: 1119000831
Size: 62.21 MB
Format: PDF
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Holland-Frei Cancer Medicine, Ninth Edition, offers a balanced view of the most current knowledge of cancer science and clinical oncology practice. This all-new edition is the consummate reference source for medical oncologists, radiation oncologists, internists, surgical oncologists, and others who treat cancer patients. A translational perspective throughout, integrating cancer biology with cancer management providing an in depth understanding of the disease An emphasis on multidisciplinary, research-driven patient care to improve outcomes and optimal use of all appropriate therapies Cutting-edge coverage of personalized cancer care, including molecular diagnostics and therapeutics Concise, readable, clinically relevant text with algorithms, guidelines and insight into the use of both conventional and novel drugs Includes free access to the Wiley Digital Edition providing search across the book, the full reference list with web links, illustrations and photographs, and post-publication updates

Genomic Clinical Trials And Predictive Medicine

Author: Richard M. Simon
Publisher: Cambridge University Press
ISBN: 1107310784
Size: 36.29 MB
Format: PDF
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Genomics is majorly impacting therapeutics development in medicine. This book contains up-to-date information on the use of genomics in the design and analysis of therapeutic clinical trials with a focus on novel approaches that provide a reliable basis for identifying which patients are most likely to benefit from each treatment. It is oriented to both clinical investigators and statisticians. For clinical investigators, it includes background information on clinical trial design and statistical analysis. For statisticians and others who want to go deeper, it covers state-of-the-art adaptive designs and the development and validation of probabilistic classifiers. The author describes the development and validation of prognostic and predictive biomarkers and their integration into clinical trials that establish their clinical utility for informing treatment decisions for future patients.

Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials

Author: Mark Chang
Publisher: Chapman & Hall/CRC Biostatisti
ISBN: 9780815379447
Size: 74.96 MB
Format: PDF, ePub
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"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Statistics In The Health Sciences

Author: Albert Vexler
Publisher: CRC Press
ISBN: 1315293765
Size: 35.50 MB
Format: PDF, Kindle
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"This very informative book introduces classical and novel statistical methods that can be used by theoretical and applied biostatisticians to develop efficient solutions for real-world problems encountered in clinical trials and epidemiological studies. The authors provide a detailed discussion of methodological and applied issues in parametric, semi-parametric and nonparametric approaches, including computationally extensive data-driven techniques, such as empirical likelihood, sequential procedures, and bootstrap methods. Many of these techniques are implemented using popular software such as R and SAS."— Vlad Dragalin, Professor, Johnson and Johnson, Spring House, PA "It is always a pleasure to come across a new book that covers nearly all facets of a branch of science one thought was so broad, so diverse, and so dynamic that no single book could possibly hope to capture all of the fundamentals as well as directions of the field. The topics within the book’s purview—fundamentals of measure-theoretic probability; parametric and non-parametric statistical inference; central limit theorems; basics of martingale theory; Monte Carlo methods; sequential analysis; sequential change-point detection—are all covered with inspiring clarity and precision. The authors are also very thorough and avail themselves of the most recent scholarship. They provide a detailed account of the state of the art, and bring together results that were previously scattered across disparate disciplines. This makes the book more than just a textbook: it is a panoramic companion to the field of Biostatistics. The book is self-contained, and the concise but careful exposition of material makes it accessible to a wide audience. This is appealing to graduate students interested in getting into the field, and also to professors looking to design a course on the subject." — Aleksey S. Polunchenko, Department of Mathematical Sciences, State University of New York at Binghamton This book should be appropriate for use both as a text and as a reference. This book delivers a "ready-to-go" well-structured product to be employed in developing advanced courses. In this book the readers can find classical and new theoretical methods, open problems and new procedures. The book presents biostatistical results that are novel to the current set of books on the market and results that are even new with respect to the modern scientific literature. Several of these results can be found only in this book.