Statistical Methods in Biomarker and Early Clinical Development

Statistical Methods in Biomarker and Early Clinical Development
Title Statistical Methods in Biomarker and Early Clinical Development PDF eBook
Author Liang Fang
Publisher Springer Nature
Pages 354
Release 2019-12-26
Genre Medical
ISBN 3030315037

Download Statistical Methods in Biomarker and Early Clinical Development Book in PDF, Epub and Kindle

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.

Biomarker Analysis in Clinical Trials with R

Biomarker Analysis in Clinical Trials with R
Title Biomarker Analysis in Clinical Trials with R PDF eBook
Author Nusrat Rabbee
Publisher CRC Press
Pages 229
Release 2020-03-11
Genre Mathematics
ISBN 0429766807

Download Biomarker Analysis in Clinical Trials with R Book in PDF, Epub and Kindle

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.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
Title Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease PDF eBook
Author Institute of Medicine
Publisher National Academies Press
Pages 335
Release 2010-06-25
Genre Medical
ISBN 0309157277

Download Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Book in PDF, Epub and Kindle

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.

Oncology Clinical Trials

Oncology Clinical Trials
Title Oncology Clinical Trials PDF eBook
Author Susan Halabi, PhD
Publisher Demos Medical Publishing
Pages 396
Release 2009-12-22
Genre Medical
ISBN 1935281763

Download Oncology Clinical Trials Book in PDF, Epub and Kindle

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

The Evaluation of Surrogate Endpoints

The Evaluation of Surrogate Endpoints
Title The Evaluation of Surrogate Endpoints PDF eBook
Author Geert Molenberghs
Publisher Springer Science & Business Media
Pages 440
Release 2005-02-28
Genre Mathematics
ISBN 9780387202778

Download The Evaluation of Surrogate Endpoints Book in PDF, Epub and Kindle

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.

Adaptive Design Methods in Clinical Trials

Adaptive Design Methods in Clinical Trials
Title Adaptive Design Methods in Clinical Trials PDF eBook
Author Shein-Chung Chow
Publisher CRC Press
Pages 368
Release 2011-12-01
Genre Mathematics
ISBN 1439839883

Download Adaptive Design Methods in Clinical Trials Book in PDF, Epub and Kindle

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini

Translational Medicine

Translational Medicine
Title Translational Medicine PDF eBook
Author Dennis Cosmatos
Publisher CRC Press
Pages 244
Release 2008-12-17
Genre Mathematics
ISBN 1584888733

Download Translational Medicine Book in PDF, Epub and Kindle

Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe 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