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Title Innovative strategies, statistical solutions and simulations for modern clinical trials / Mark Chang, John Balser, Jim Roach and Robin Bliss.
Imprint Boca Raton, FL : CRC Press/Taylor & Francis, [2019]


 Internet  Electronic Book    AVAILABLE
Description 1 online resource (xiv, 361 pages) : illustrations
Series Chapman and Hall/CRC Biostatistics Ser.
Chapman & Hall/CRC biostatistics series.
Bibliog. Includes bibliographical references and index.
Note 5.3 Overview of Biomarker-Adaptive Designs
Available only to authorized UTEP users.
Bio/Hist Note Dr. Mark Chang is Sr. Vice President, Strategic Statistical Consulting at Veristat. Before joining Veristat, Chang served various strategic roles in AMAG and Millennium Pharmaceuticals, including Vice President of Biometrics at AMAG and director and scientific fellow at Millennium/Takeda. Chang is a fellow of the American Statistical Association and an adjunct professor of Biostatistics at Boston University. He is a co-founder of the International Society for Biopharmaceutical Statistics, co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group, and a member of the Multiregional Clinical Trial (MRCT) Expert Group. Hehas published 11 books, including Monte Carlo Simulation for the Pharmaceutical Industry, Adaptive Design Theory and Implementation Using SAS and R, Modern Issues and Methods in Biostatistics, Paradoxes in Scientific Inference, and Principles of Scientific Methods. John Balser, PhD, co-founder and President of Veristat, has developed the company as industry leaders in areas of clinical monitoring, data management, biostatistics and programming, medical writing, and project management. John is actively involved with clinical projects in his role as one of Veristat's principal statistical consultants. In this role, he assists clients with clinical study design and program development based on his many years of experience in the statistical aspects of clinical research. He is often called upon to assist clients on a variety of statistical issues at meetings with regulatory agencies. Prior to founding Veristat in 1994, John served as Vice President, Biostatistics, and Data Management at Medical & Technical Research Associates, Inc. He has held positions of increasing responsibility in the biostatistics departments at various pharmaceutical companies including E.R. Squibb, Biogen, and Miles. John received his MS and PhD in Biometrics from Cornell University, and has been actively engaged in clinical biostatistics for over 25 years. John is an avid runner and has competed in the Boston Marathon. Robin Bliss, PhD joined Veristat in October, 2011 and has served as Director, Biostatistics since October, 2017. Through her experience at Veristat, Dr. Bliss has implemented complex adaptive designs across clinical trials in Phases I, II, and III as well as seamless Phase I/II and II/III trials. She has also provided strategic advice to sponsor companies, including representation of such companies at regulatory agencies, participation with scientific advisory committees, performance of simulation studies, and other consulting services. Dr. Bliss has taught conference short courses in adaptive design as well as statistical courses as a university adjunct faculty member. Prior to Veristat, Dr. Bliss held a post-doctoral fellowship position at Brigham and Women's Hospital (Boston) in the Orthopedic and Arthritics Center for Outcomes Research. Dr. Bliss earned her PhD in Biostatistics from Boston University where her research focused on spatial and environmental statistics. James M. Roach, MD, FACP, FCCP joined Pulmatrix as their Chief Medical Officer (CMO) in November 2017. Dr. Roach served as the CMO at Veristat, Inc for the year prior to joining Pulmatrix, and prior to Veristat served as the Senior Vice President, Development and CMO at Momenta Pharmaceuticals, Inc. from 2008-2016. From 2002-2008 Dr. Roach was the Senior Vice President, Medical Affairs at Sepracor, Inc. Dr. Roach has also held senior clinical research and/or medical affairs positions at Millennium Pharmaceuticals, Inc., LeukoSite, Inc., Medical and Technical Research Associates, Inc. and Astra USA. Dr. Roach held an academic appointment at Harvard Medical School for close to 25 years and has been an Associate Physician at Brigham and Women's Hospital (BWH) and member of the BWH Pulmonary and Critical Care Medicine Division since 1993. He received his B.A. in Biology and Philosophy from the College of the Holy Cross and his M.D. from Georgetown University School of Medicine. Dr. Roach completed his residency in Internal Medicine and fellowships in Pulmonary Disease and Critical Care Medicine at Walter Reed Army Medical Center in Washington, D.C., and served in the US Army Medical Corps for ten years. Dr. Roach is board certified in Internal Medicine and Pulmonary Disease, and is a Fellow of the American College of Physicians (ACP) and the American College of Chest Physicians (ACCP).
Note Description based on print version record.
Subject Clinical trials -- Statistical methods.
Clinical Trials as Topic.
Statistics as Topic.
Research Design.
Drug Approval.
Contents Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Author Bio; 1: Overview of Drug Development; 1.1 Introduction; 1.2 Drug Discovery; 1.2.1 Target Identification and Validation; 1.2.2 Irrational Approach; 1.2.3 Rational Approach; 1.2.4 Biologics; 1.2.5 NanoMedicine; 1.3 Preclinical Development; 1.3.1 Objectives of Preclinical Development; 1.3.2 Pharmacokinetics; 1.3.3 Pharmacodynamics; 1.3.4 Toxicology; 1.3.5 Intraspecies and Interspecies Scaling; 1.4 Clinical Development; 1.4.1 Overview of Clinical Development; 1.4.2 Classical Clinical Trial Paradigm
1.4.3 Adaptive Trial Design Paradigm1.4.4 New Drug Application; 1.5 Summary; 2: Clinical Development Plan and Clinical Trial Design; 2.1 Clinical Development Program; 2.1.1 Unmet Medical Needs & Competitive Landscape; 2.1.2 Therapeutic Areas; 2.1.3 Value proposition; 2.1.4 Prescription Drug Global Pricing; 2.1.5 Clinical Development Plan; 2.2 Clinical Trials; 2.2.1 Placebo, Blinding and Randomization; 2.2.2 Trial Design Type; 2.2.3 Confounding Factors; 2.2.4 Variability and Bias; 2.2.5 Randomization Procedure; 2.2.6 Clinical Trial Protocol; 2.2.7 Target Population; 2.2.8 Endpoint Selection
2.2.9 Proof of Concept Trial2.2.10 Sample Size and Power; 2.2.11 Bayesian Power for Classical Design; 2.3 Summary; 3: Clinical Development Optimization; 3.1 Benchmarks in Clinical Development; 3.1.1 Net Present Value and Risk-Adjusted NPV Method; 3.1.2 Clinical Program Success Rates; 3.1.3 Failure Rates by Reason; 3.1.4 Costs of Clinical Trials; 3.1.5 Time-to-Next Phase, Clinical Trial Length and Regulatory Review Time; 3.1.6 Rates of Competitor Emerging; 3.2 Optimization of Clinical Development Program; 3.2.1 Local Versus Global Optimizations
3.2.2 Stochastic Decision Process for Drug Development3.2.3 Time Dependent Gain g4,; 3.2.4 Determination of Transition Probabilities; 3.2.5 Example of CDP Optimization; 3.2.6 Updating Model Parameters; 3.2.7 Clinical Development Program with Adaptive Design; 3.3 Summary; 4: Globally Optimal Adaptive Trial Designs; 4.1 Common Adaptive Designs; 4.2 Group Sequential Design; 4.2.1 Test Statistics; 4.2.2 Commonly Used Stopping Boundaries; 4.3 Sample Size Reestimation Design; 4.3.1 Test Statistic; 4.3.2 Rules of Stopping and Sample-Size Adjustment; 4.3.3 Simulation Examples; 4.4 Pick-Winner-Design
4.4.1 Shun-Lan-Soo Method for Three-Arm Design4.4.2 K-Arm Pick-Winner Design; 4.5 Global Optimization of Adaptive Design -- Case Study; 4.5.1 Medical Needs for COPD; 4.5.2 COPD Market; 4.5.3 Indacaterol Trials; 4.5.4 US COPD Phase II Trial Results; 4.5.5 Optimal Design; 4.6 Summary & Discussions; 5: Trial Design for Precision Medicine; 5.1 Introduction; 5.2 Overview of Classical Designs with Biomarkers; 5.2.1 Biomarker-enrichment Design; 5.2.2 Biomarker-Stratified Design; 5.2.3 Sequential Testing Strategy Design; 5.2.4 Marker-based Strategy Design; 5.2.5 Hybrid Design
Summary "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.
Other Author Balser, John, author
Bliss, Robin, author
Roach, Jim (James Michael), 1959- author.
Other Title Print version: Chang, Mark. Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials. Milton : Chapman and Hall/CRC, ©2019 9780815379447