Data and Safety Monitoring Committees in Clinical Trials (Chapman & Hall/CRC Biostatistics Series)

The importance of discrete and combinatorial mathematics continues to increase as the range of applications to computer science, electrical engineering, and the biological sciences grows dramatically. Providing a ready reference for practitioners in the field, the Handbook of Discrete and Combinatorial Mathematics, Second Edition presents additional material on Google's matrix, random graphs, geometric graphs, computational topology, and other key topics. New chapters highlight essential background information on bioinformatics and computational geometry. Each chapter includes a glossary, definitions, facts, examples, algorithms, major applications, and references. Praise for the first edition:'Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC.'-S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

The importance of discrete mathematics has increased dramatically within the last few years but until now, it has been difficult-if not impossible-to find a single reference book that effectively covers the subject. To fill that void, The Handbook of Discrete and Combinatorial Mathematics presents a comprehensive collection of ready reference material for all of the important areas of discrete mathematics, including those essential to its applications in computer science and engineering. Its topics include:

Logic and foundations

Counting

Number theory

Abstract and linear algebra

Probability

Graph theory

Networks and optimization

Cryptography and coding

Combinatorial designs The author presents the material in a simple, uniform way, and emphasizes what is useful and practical. For easy reference, he incorporates into the text:

Many glossaries of important terms

Lists of important theorems and formulas

Numerous examples that illustrate terms and concepts

Helpful descriptions of algorithms

Summary tables

Citations of Web pages that supplement the text If you have ever had to find information from discrete mathematics in your work-or just out of curiosity-you probably had to search through a variety of books to find it. Never again. The Handbook of Discrete Mathematics is now available and has virtually everything you need-everything important to both theory and practice.

Booknews

A reference to all the important areas of discrete mathematics, including those essential to its applications in computer science and engineering. The topics include logic and foundations, number theory, discrete probability, networks and optimization, combinatorial designs, and computational geometry. Among the features are glossaries, lists of important theorems and formulas, examples illustrating terms and concepts, descriptions of algorithms, summary tables, pointers to print and non-print resources, and biographical sketches of important figures. Annotation c. Book News, Inc., Portland, OR (booknews.com)

The importance of discrete mathematics has increased dramatically within the last few years but until now, it has been difficult-if not impossible-to find a single reference book that effectively covers the subject. To fill that void, The Handbook of Discrete and Combinatorial Mathematics presents a comprehensive collection of ready reference material for all of the important areas of discrete mathematics, including those essential to its applications in computer science and engineering. Its topics include: Logic and foundations Counting Number theory Abstract and linear algebra Probability Graph theory Networks and optimization Cryptography and coding Combinatorial designs The author presents the material in a simple, uniform way, and emphasizes what is useful and practical. For easy reference, he incorporates into the text: Many glossaries of important terms Lists of important theorems and formulas Numerous examples that illustrate terms and concepts Helpful descriptions of algorithms Summary tables Citations of Web pages that supplement the text If you have ever had to find information from discrete mathematics in your work-or just out of curiosity-you probably had to search through a variety of books to find it. Never again. The Handbook of Discrete Mathematics is now available and has virtually everything you need-everything important to both theory and practice.

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed.

The importance of discrete mathematics has increased dramatically within the last few years, but until now it has been difficult -- if not impossible -- to find a single reference book that effectively covers the subject. To fill that void, the Handbook of Discrete and Combinatorial Mathematics presents a comprehensive collection of ready reference material for all of the important areas of discrete mathematics, including those essential to its applications in computer science and engineering. "Handbook of Discrete and Combinatorial Mathematics presents a comprehensive collection of ready reference material for all of the important areas of discrete mathematics, including those essential to its applications in computer science and engineering." "Whether you're an engineer, computer professional, student, or someone interested in math, you will find this book incredibly useful."--Jacket. Focuses on the practical clinical and statistical issues that arise in pharmaceutical industry trials. This book explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. It also how physicians think differently about safety data than statisticians. Organization of a safety monitoring program Meetings Clinical issues Statistical issues Bias and pitfalls Data monitoring committee decisions Emerging issues.