Contemporary Biostatistics With Biopharmaceutical Applications

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Contemporary Biostatistics with Biopharmaceutical Applications

Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan
Contemporary Biostatistics with Biopharmaceutical Applications Book PDF

Author : Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan
Publisher : Springer
Page : 339 pages
File Size : 46,6 Mb
Release : 2019-07-11
Category : Medical
ISBN : 9783030153106

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Contemporary Biostatistics with Biopharmaceutical Applications by Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan Pdf

This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications. Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.

Contemporary Biostatistics with Biopharmaceutical Applications

Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan
Contemporary Biostatistics with Biopharmaceutical Applications Book PDF

Author : Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan
Publisher : Unknown
Page : 336 pages
File Size : 55,8 Mb
Release : 2019
Category : Electronic books
ISBN : 3030153118

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Contemporary Biostatistics with Biopharmaceutical Applications by Lanju Zhang,Ding-Geng (Din) Chen,Hongmei Jiang,Gang Li,Hui Quan Pdf

This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for A New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications. Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.

Clinical Trial Biostatistics and Biopharmaceutical Applications

Walter R. Young,Ding-Geng (Din) Chen
Clinical Trial Biostatistics and Biopharmaceutical Applications Book PDF

Author : Walter R. Young,Ding-Geng (Din) Chen
Publisher : CRC Press
Page : 574 pages
File Size : 48,9 Mb
Release : 2014-11-20
Category : Mathematics
ISBN : 9781482212198

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Clinical Trial Biostatistics and Biopharmaceutical Applications by Walter R. Young,Ding-Geng (Din) Chen Pdf

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

Design and Analysis of Subgroups with Biopharmaceutical Applications

Naitee Ting,Joseph C. Cappelleri,Shuyen Ho,(Din) Ding-Geng Chen
Design and Analysis of Subgroups with Biopharmaceutical Applications Book PDF

Author : Naitee Ting,Joseph C. Cappelleri,Shuyen Ho,(Din) Ding-Geng Chen
Publisher : Springer Nature
Page : 404 pages
File Size : 54,5 Mb
Release : 2020-05-01
Category : Medical
ISBN : 9783030401054

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Design and Analysis of Subgroups with Biopharmaceutical Applications by Naitee Ting,Joseph C. Cappelleri,Shuyen Ho,(Din) Ding-Geng Chen Pdf

This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statistical and methodological developments, and potential future directions. The volume covers topics in subgroups in clinical trial design; subgroup identification and personalized medicine; and general issues in subgroup analyses, including regulatory ones. Included chapters present current methods, theories, and case applications in the diverse field of subgroup application and analysis. Offering timely perspectives from a range of authoritative sources, the volume is designed to have wide appeal to professionals in the pharmaceutical industry and to graduate students and researchers in academe and government.

Modern Issues and Methods in Biostatistics

Mark Chang
Modern Issues and Methods in Biostatistics Book PDF

Author : Mark Chang
Publisher : Springer Science & Business Media
Page : 316 pages
File Size : 50,7 Mb
Release : 2011-07-15
Category : Medical
ISBN : 9781441998422

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Modern Issues and Methods in Biostatistics by Mark Chang Pdf

Classic biostatistics, a branch of statistical science, has as its main focus the applications of statistics in public health, the life sciences, and the pharmaceutical industry. Modern biostatistics, beyond just a simple application of statistics, is a confluence of statistics and knowledge of multiple intertwined fields. The application demands, the advancements in computer technology, and the rapid growth of life science data (e.g., genomics data) have promoted the formation of modern biostatistics. There are at least three characteristics of modern biostatistics: (1) in-depth engagement in the application fields that require penetration of knowledge across several fields, (2) high-level complexity of data because they are longitudinal, incomplete, or latent because they are heterogeneous due to a mixture of data or experiment types, because of high-dimensionality, which may make meaningful reduction impossible, or because of extremely small or large size; and (3) dynamics, the speed of development in methodology and analyses, has to match the fast growth of data with a constantly changing face. This book is written for researchers, biostatisticians/statisticians, and scientists who are interested in quantitative analyses. The goal is to introduce modern methods in biostatistics and help researchers and students quickly grasp key concepts and methods. Many methods can solve the same problem and many problems can be solved by the same method, which becomes apparent when those topics are discussed in this single volume.

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 245 pages
File Size : 43,5 Mb
Release : 2018-08-21
Category : Medical
ISBN : 9789811078262

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Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep Menon Pdf

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.

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 426 pages
File Size : 43,6 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9789811078200

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Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep Menon Pdf

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 third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep M. Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep M. Menon
Publisher : Unknown
Page : 128 pages
File Size : 47,7 Mb
Release : 2018
Category : Biopharmaceutics
ISBN : 9811078211

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Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep M. Menon Pdf

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 third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine - Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Introductory Biostatistics for the Health Sciences

Michael R. Chernick,Robert H. Friis
Introductory Biostatistics for the Health Sciences Book PDF

Author : Michael R. Chernick,Robert H. Friis
Publisher : John Wiley & Sons
Page : 426 pages
File Size : 46,9 Mb
Release : 2003-06-24
Category : Mathematics
ISBN : 9780471458654

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Introductory Biostatistics for the Health Sciences by Michael R. Chernick,Robert H. Friis Pdf

"Introductory Biostatistics for the Health Sciences" ist eine fundierte Einführung in die Biostatistik und ihre Anwendungsgebiete. Der Band richtet sich vorwiegend an Mediziner und Statistiker. Theorie und Praxis stehen im ausgewogenen Verhältnis, d.h. praktische Anwendungen werden, wo nötig, durch den theoretischen Hintergrund ergänzt. Der Schwerpunkt liegt eindeutig auf der praktischen Anwendung. Der Band geht auch auf jüngste Fortschritte bei der Bootstrap-, Outlier- und Meta-Analyse ein, Themen, die in der Regel in Konkurrenzwerken, nicht behandelt werden. Mit einer Fülle von Übungsaufgaben. Auch Statistiksoftware wird ausführlich besprochen.

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 409 pages
File Size : 44,5 Mb
Release : 2018-08-20
Category : Medical
ISBN : 9789811078293

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Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep Menon Pdf

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 first of the 3-volume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.

Biostatistical Applications in Cancer Research

Craig Beam
Biostatistical Applications in Cancer Research Book PDF

Author : Craig Beam
Publisher : Springer Science & Business Media
Page : 242 pages
File Size : 48,6 Mb
Release : 2013-03-14
Category : Medical
ISBN : 9781475735710

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Biostatistical Applications in Cancer Research by Craig Beam Pdf

Biostatistics is defined as much by its application as it is by theory. This book provides an introduction to biostatistical applications in modern cancer research that is both accessible and valuable to the cancer biostatistician or to the cancer researcher, learning biostatistics. The topical areas include active areas of the application of biostatistics to modern cancer research: survival analysis, screening, diagnostics, spatial analysis and the analysis of microarray data. Biostatistics is an essential component of basic and clinical cancer research. The text, authored by distinguished figures in the field, addresses clinical issues in statistical analysis. The spectrum of topics discussed ranges from fundamental methodology to clinical and translational applications.

Biopharmaceutical Sequential Statistical Applications

Karl E. Peace
Biopharmaceutical Sequential Statistical Applications Book PDF

Author : Karl E. Peace
Publisher : CRC Press
Page : 377 pages
File Size : 44,8 Mb
Release : 1992-03-25
Category : Mathematics
ISBN : 9781482277128

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Biopharmaceutical Sequential Statistical Applications by Karl E. Peace Pdf

Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep M. Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep M. Menon
Publisher : Unknown
Page : 128 pages
File Size : 41,8 Mb
Release : 2018
Category : Biopharmaceutics
ISBN : 9811078270

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Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep M. Menon Pdf

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.

Mathematical and Statistical Skills in the Biopharmaceutical Industry

Arkadiy Pitman
Mathematical and Statistical Skills in the Biopharmaceutical Industry Book PDF

Author : Arkadiy Pitman
Publisher : CRC Press
Page : 220 pages
File Size : 44,7 Mb
Release : 2019-07-15
Category : Business & Economics
ISBN : 9781498769808

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Mathematical and Statistical Skills in the Biopharmaceutical Industry by Arkadiy Pitman Pdf

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’ experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials

Mark Chang,John Balser,Jim Roach,Robin Bliss
Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials Book PDF

Author : Mark Chang,John Balser,Jim Roach,Robin Bliss
Publisher : CRC Press
Page : 218 pages
File Size : 49,6 Mb
Release : 2019-03-20
Category : Mathematics
ISBN : 9781351214520

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Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials by Mark Chang,John Balser,Jim Roach,Robin Bliss Pdf

"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.