Statistical Methods In Biomarker And Early Clinical Development

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Statistical Methods in Biomarker and Early Clinical Development

Author : Liang Fang
Publisher : Springer Nature
ISBN 13 : 3030315037
Total Pages : 354 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Statistical Methods in Biomarker and Early Clinical Development by : Liang Fang

Download or read book Statistical Methods in Biomarker and Early Clinical Development written by Liang Fang and published by Springer Nature. This book was released on 2019-12-26 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.

Statistical Approaches in Oncology Clinical Development

Author : Satrajit Roychoudhury
Publisher : CRC Press
ISBN 13 : 1351650475
Total Pages : 243 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Statistical Approaches in Oncology Clinical Development by : Satrajit Roychoudhury

Download or read book Statistical Approaches in Oncology Clinical Development written by Satrajit Roychoudhury and published by CRC Press. This book was released on 2018-12-07 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. 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 contributors 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 (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

Biomarker Analysis in Clinical Trials with R

Author : Nusrat Rabbee
Publisher : CRC Press
ISBN 13 : 0429766807
Total Pages : 204 pages
Book Rating : 4.4/5 (297 download)

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Book Synopsis Biomarker Analysis in Clinical Trials with R by : Nusrat Rabbee

Download or read book Biomarker Analysis in Clinical Trials with R written by Nusrat Rabbee and published by CRC Press. This book was released on 2020-03-11 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into communicating, understanding and synthesizing biomarker data. -From the Foreword, Jared Christensen, Vice President, Biostatistics Early Clinical Development, Pfizer, Inc. Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers. Features: Analysis of pharmacodynamic biomarkers for lending evidence target modulation. Design and analysis of trials with a predictive biomarker. Framework for analyzing surrogate biomarkers. Methods for combining multiple biomarkers to predict treatment response. Offers a biomarker statistical analysis plan. R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.

Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials

Author : Mark Chang
Publisher : CRC Press
ISBN 13 : 1351214535
Total Pages : 362 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials by : Mark Chang

Download or read book Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials written by Mark Chang and published by CRC Press. This book was released on 2019-03-20 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.

Translational Medicine

Author : Dennis Cosmatos
Publisher : CRC Press
ISBN 13 : 9781584888734
Total Pages : 224 pages
Book Rating : 4.8/5 (887 download)

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Book Synopsis Translational Medicine by : Dennis Cosmatos

Download or read book Translational Medicine written by Dennis Cosmatos and published by CRC Press. This book was released on 2008-12-17 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies that lead to regulatory approval of drug release to patients. Translational Medicine: Strategies and Statistical Methods suggests a process for transitioning from the initial lab discovery to the patient’s bedside with minimal disconnect and offers a comprehensive review of statistical design and methodology commonly employed in this bench-to-bedside research. Documents Alternative Research Approaches for Faster and More Accurate Data Judgment Calls Elaborating on how to introduce TM into clinical studies, this authoritative work presents a keen approach to building, executing, and validating statistical models that consider data from various phases of development. It also delineates a truly translational example to help bolster understanding of discussed concepts. This comprehensive guide effectively demonstrates how to overcome obstacles related to successful TM practice. It contains invaluable information for pharmaceutical scientists, research executives, clinicians, and biostatisticians looking to expedite successful implementation of this important process.

Introduction to Statistical Methods for Clinical Trials

Author : Thomas D. Cook
Publisher : CRC Press
ISBN 13 : 1420009966
Total Pages : 452 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Introduction to Statistical Methods for Clinical Trials by : Thomas D. Cook

Download or read book Introduction to Statistical Methods for Clinical Trials written by Thomas D. Cook and published by CRC Press. This book was released on 2007-11-19 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors' collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various stati

Advanced Statistics in Regulatory Critical Clinical Initiatives

Author : Wei Zhang
Publisher : CRC Press
ISBN 13 : 1000567990
Total Pages : 318 pages
Book Rating : 4.0/5 (5 download)

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Book Synopsis Advanced Statistics in Regulatory Critical Clinical Initiatives by : Wei Zhang

Download or read book Advanced Statistics in Regulatory Critical Clinical Initiatives written by Wei Zhang and published by CRC Press. This book was released on 2022-05-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

The Statistical Evaluation of Medical Tests for Classification and Prediction

Author : Margaret Sullivan Pepe
Publisher : OUP Oxford
ISBN 13 : 019158861X
Total Pages : 319 pages
Book Rating : 4.1/5 (915 download)

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Book Synopsis The Statistical Evaluation of Medical Tests for Classification and Prediction by : Margaret Sullivan Pepe

Download or read book The Statistical Evaluation of Medical Tests for Classification and Prediction written by Margaret Sullivan Pepe and published by OUP Oxford. This book was released on 2003-03-13 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests, biomarkers and new technologies for classification and prediction in medicine.

Comprehensive Biomarker Discovery and Validation for Clinical Application

Author : Péter Horvatovich
Publisher : Royal Society of Chemistry
ISBN 13 : 1849734224
Total Pages : 385 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Comprehensive Biomarker Discovery and Validation for Clinical Application by : Péter Horvatovich

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.

Clinical Trial Biostatistics and Biopharmaceutical Applications

Author : Walter R. Young
Publisher : CRC Press
ISBN 13 : 1482212188
Total Pages : 582 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Clinical Trial Biostatistics and Biopharmaceutical Applications by : Walter R. Young

Download or read book Clinical Trial Biostatistics and Biopharmaceutical Applications written by Walter R. Young and published by CRC Press. This book was released on 2014-11-20 with total page 582 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints. This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.

Clinical and Statistical Considerations in Personalized Medicine

Author : Claudio Carini
Publisher : CRC Press
ISBN 13 : 1466593873
Total Pages : 376 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Clinical and Statistical Considerations in Personalized Medicine by : Claudio Carini

Download or read book Clinical and Statistical Considerations in Personalized Medicine written by Claudio Carini and published by CRC Press. This book was released on 2014-03-27 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Analysis of Biomarker Data

Author : Stephen W. Looney
Publisher : John Wiley & Sons
ISBN 13 : 1118552458
Total Pages : 424 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Analysis of Biomarker Data by : Stephen W. Looney

Download or read book Analysis of Biomarker Data written by Stephen W. Looney and published by John Wiley & Sons. This book was released on 2015-01-28 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: A “how to” guide for applying statistical methods to biomarker data analysis Presenting a solid foundation for the statistical methods that are used to analyze biomarker data, Analysis of Biomarker Data: A Practical Guide features preferred techniques for biomarker validation. The authors provide descriptions of select elementary statistical methods that are traditionally used to analyze biomarker data with a focus on the proper application of each method, including necessary assumptions, software recommendations, and proper interpretation of computer output. In addition, the book discusses frequently encountered challenges in analyzing biomarker data and how to deal with them, methods for the quality assessment of biomarkers, and biomarker study designs. Covering a broad range of statistical methods that have been used to analyze biomarker data in published research studies, Analysis of Biomarker Data: A Practical Guide also features: A greater emphasis on the application of methods as opposed to the underlying statistical and mathematical theory The use of SAS®, R, and other software throughout to illustrate the presented calculations for each example Numerous exercises based on real-world data as well as solutions to the problems to aid in reader comprehension The principles of good research study design and the methods for assessing the quality of a newly proposed biomarker A companion website that includes a software appendix with multiple types of software and complete data sets from the book’s examples Analysis of Biomarker Data: A Practical Guide is an ideal upper-undergraduate and graduate-level textbook for courses in the biological or environmental sciences. An excellent reference for statisticians who routinely analyze and interpret biomarker data, the book is also useful for researchers who wish to perform their own analyses of biomarker data, such as toxicologists, pharmacologists, epidemiologists, environmental and clinical laboratory scientists, and other professionals in the health and environmental sciences.

Oncology Clinical Trials

Author : Susan Halabi, PhD
Publisher : Demos Medical Publishing
ISBN 13 : 9781935281764
Total Pages : 168 pages
Book Rating : 4.2/5 (817 download)

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Book Synopsis Oncology Clinical Trials by : Susan Halabi, PhD

Download or read book Oncology Clinical Trials written by Susan Halabi, PhD and published by Demos Medical Publishing. This book was released on 2009-12-22 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Biomarkers in Drug Development

Author : Michael R. Bleavins
Publisher : John Wiley & Sons
ISBN 13 : 1118210425
Total Pages : 559 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Biomarkers in Drug Development by : Michael R. Bleavins

Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher : Springer
ISBN 13 : 9811078262
Total Pages : 245 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Biopharmaceutical Applied Statistics Symposium by : Karl E. Peace

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-08-21 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.

Advanced Medical Statistics

Author : Ying Lu
Publisher : World Scientific
ISBN 13 : 9789810248000
Total Pages : 1118 pages
Book Rating : 4.2/5 (48 download)

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Book Synopsis Advanced Medical Statistics by : Ying Lu

Download or read book Advanced Medical Statistics written by Ying Lu and published by World Scientific. This book was released on 2003 with total page 1118 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents new and powerful advanced statistical methods that have been used in modern medicine, drug development, and epidemiology. Some of these methods were initially developed for tackling medical problems. All 29 chapters are self-contained. Each chapter represents the new development and future research topics for a medical or statistical branch. For the benefit of readers with different statistical background, each chapter follows a similar style: the explanation of medical challenges, statistical ideas and strategies, statistical methods and techniques, mathematical remarks and background and reference. All chapters are written by experts of the respective topics.