Handbook Of Methods For Designing Monitoring And Analyzing Dose Finding Trials

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Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials

Author : John O'Quigley
Publisher : CRC Press
ISBN 13 : 149874611X
Total Pages : 306 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials by : John O'Quigley

Download or read book Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials written by John O'Quigley and published by CRC Press. This book was released on 2017-04-27 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies. John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry.

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials

Author : John O'Quigley
Publisher : CRC Press
ISBN 13 : 1351648020
Total Pages : 410 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials by : John O'Quigley

Download or read book Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials written by John O'Quigley and published by CRC Press. This book was released on 2017-04-27 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies. John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry.

Handbook of Methods for Designing and Monitoring Dose Finding Trials

Author : John O'Quigley
Publisher : Chapman & Hall/CRC
ISBN 13 : 9781498746106
Total Pages : 0 pages
Book Rating : 4.7/5 (461 download)

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Book Synopsis Handbook of Methods for Designing and Monitoring Dose Finding Trials by : John O'Quigley

Download or read book Handbook of Methods for Designing and Monitoring Dose Finding Trials written by John O'Quigley and published by Chapman & Hall/CRC. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook will provide an overview of most up-to-date statistical methods required for design, monitoring and analysis for dose finding clinical trials, focusing both on the clinical aspects as well as statistical considerations. This handbook will not cover statistical methods for Phase II non-dose finding studies or Phase III clinical trials.

Dose-Finding Designs for Early-Phase Cancer Clinical Trials

Author : Takashi Daimon
Publisher : Springer
ISBN 13 : 4431555854
Total Pages : 133 pages
Book Rating : 4.4/5 (315 download)

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Book Synopsis Dose-Finding Designs for Early-Phase Cancer Clinical Trials by : Takashi Daimon

Download or read book Dose-Finding Designs for Early-Phase Cancer Clinical Trials written by Takashi Daimon and published by Springer. This book was released on 2019-05-21 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.

Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents

Author : Akihiro Hirakawa
Publisher : Springer
ISBN 13 : 4431555730
Total Pages : 100 pages
Book Rating : 4.4/5 (315 download)

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Book Synopsis Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents by : Akihiro Hirakawa

Download or read book Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents written by Akihiro Hirakawa and published by Springer. This book was released on 2018-01-30 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) in oncology. It provides not only methodological aspects of the dose-finding methods, but also software implementations and practical considerations in applying these complex methods to real cancer clinical trials. Thus, the book aims to furnish researchers in biostatistics and statistical science with a good summary of recent developments of adaptive dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing adaptive dose-finding trials. The topics in the book are mainly related to cancer clinical trials, but many of those topics are potentially applicable or can be extended to trials for other diseases. The focus is mainly on model-based dose-finding methods for two kinds of phase I trials. One is clinical trials with combinations of two agents. Development of dose-finding methods for two-agent combination trials requires reasonable models that can adequately capture joint toxicity probabilities for two agents, taking into consideration possible interactions of the two agents on toxicity probability such as synergistic or antagonistic effects. Another is clinical trials for evaluating both efficacy and toxicity outcomes in single- and two-agent combination trials. These methods are often applied to the phase I trials including MTAs because the toxicity and efficacy for a MTA does not monotonically increase with dose, but the efficacy often increases initially with the dose and then plateaus. Successful software implementations for several dose-finding methods are introduced in the book, and their operating characteristics in practice are discussed. Recent advance of the adaptive dose-finding methods in drug developments are also provided.

Handbook of Multiple Comparisons

Author : Xinping Cui
Publisher : CRC Press
ISBN 13 : 0429633882
Total Pages : 418 pages
Book Rating : 4.4/5 (296 download)

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Book Synopsis Handbook of Multiple Comparisons by : Xinping Cui

Download or read book Handbook of Multiple Comparisons written by Xinping Cui and published by CRC Press. This book was released on 2021-11-18 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by experts that include originators of some key ideas, chapters in the Handbook of Multiple Testing cover multiple comparison problems big and small, with guidance toward error rate control and insights on how principles developed earlier can be applied to current and emerging problems. Some highlights of the coverages are as follows. Error rate control is useful for controlling the incorrect decision rate. Chapter 1 introduces Tukey's original multiple comparison error rates and point to how they have been applied and adapted to modern multiple comparison problems as discussed in the later chapters. Principles endure. While the closed testing principle is more familiar, Chapter 4 shows the partitioning principle can derive confidence sets for multiple tests, which may become important as the profession goes beyond making decisions based on p-values. Multiple comparisons of treatment efficacy often involve multiple doses and endpoints. Chapter 12 on multiple endpoints explains how different choices of endpoint types lead to different multiplicity adjustment strategies, while Chapter 11 on the MCP-Mod approach is particularly useful for dose-finding. To assess efficacy in clinical trials with multiple doses and multiple endpoints, the reader can see the traditional approach in Chapter 2, the Graphical approach in Chapter 5, and the multivariate approach in Chapter 3. Personalized/precision medicine based on targeted therapies, already a reality, naturally leads to analysis of efficacy in subgroups. Chapter 13 draws attention to subtle logical issues in inferences on subgroups and their mixtures, with a principled solution that resolves these issues. This chapter has implication toward meeting the ICHE9R1 Estimands requirement. Besides the mere multiple testing methodology itself, the handbook also covers related topics like the statistical task of model selection in Chapter 7 or the estimation of the proportion of true null hypotheses (or, in other words, the signal prevalence) in Chapter 8. It also contains decision-theoretic considerations regarding the admissibility of multiple tests in Chapter 6. The issue of selected inference is addressed in Chapter 9. Comparison of responses can involve millions of voxels in medical imaging or SNPs in genome-wide association studies (GWAS). Chapter 14 and Chapter 15 provide state of the art methods for large scale simultaneous inference in these settings.

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 135111025X
Total Pages : 4057 pages
Book Rating : 4.3/5 (511 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics - Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 4057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Platform Trial Designs in Drug Development

Author : Zoran Antonijevic
Publisher : CRC Press
ISBN 13 : 1351683934
Total Pages : 304 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Platform Trial Designs in Drug Development by : Zoran Antonijevic

Download or read book Platform Trial Designs in Drug Development written by Zoran Antonijevic and published by CRC Press. This book was released on 2018-12-07 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.

Handbook of Statistical Methods for Case-Control Studies

Author : Ørnulf Borgan
Publisher : CRC Press
ISBN 13 : 1498768598
Total Pages : 536 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Handbook of Statistical Methods for Case-Control Studies by : Ørnulf Borgan

Download or read book Handbook of Statistical Methods for Case-Control Studies written by Ørnulf Borgan and published by CRC Press. This book was released on 2018-06-27 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Statistical Methods for Case-Control Studies is written by leading researchers in the field. It provides an in-depth treatment of up-to-date and currently developing statistical methods for the design and analysis of case-control studies, as well as a review of classical principles and methods. The handbook is designed to serve as a reference text for biostatisticians and quantitatively-oriented epidemiologists who are working on the design and analysis of case-control studies or on related statistical methods research. Though not specifically intended as a textbook, it may also be used as a backup reference text for graduate level courses. Book Sections Classical designs and causal inference, measurement error, power, and small-sample inference Designs that use full-cohort information Time-to-event data Genetic epidemiology About the Editors Ørnulf Borgan is Professor of Statistics, University of Oslo. His book with Andersen, Gill and Keiding on counting processes in survival analysis is a world classic. Norman E. Breslow was, at the time of his death, Professor Emeritus in Biostatistics, University of Washington. For decades, his book with Nick Day has been the authoritative text on case-control methodology. Nilanjan Chatterjee is Bloomberg Distinguished Professor, Johns Hopkins University. He leads a broad research program in statistical methods for modern large scale biomedical studies. Mitchell H. Gail is a Senior Investigator at the National Cancer Institute. His research includes modeling absolute risk of disease, intervention trials, and statistical methods for epidemiology. Alastair Scott was, at the time of his death, Professor Emeritus of Statistics, University of Auckland. He was a major contributor to using survey sampling methods for analyzing case-control data. Chris J. Wild is Professor of Statistics, University of Auckland. His research includes nonlinear regression and methods for fitting models to response-selective data.

Handbook of Statistical Methods for Randomized Controlled Trials

Author : KyungMann Kim
Publisher : CRC Press
ISBN 13 : 1498714641
Total Pages : 655 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Handbook of Statistical Methods for Randomized Controlled Trials by : KyungMann Kim

Download or read book Handbook of Statistical Methods for Randomized Controlled Trials written by KyungMann Kim and published by CRC Press. This book was released on 2021-08-23 with total page 655 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.

Handbook of Infectious Disease Data Analysis

Author : Leonhard Held
Publisher : CRC Press
ISBN 13 : 1351839322
Total Pages : 554 pages
Book Rating : 4.3/5 (518 download)

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Book Synopsis Handbook of Infectious Disease Data Analysis by : Leonhard Held

Download or read book Handbook of Infectious Disease Data Analysis written by Leonhard Held and published by CRC Press. This book was released on 2019-11-07 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent years have seen an explosion in new kinds of data on infectious diseases, including data on social contacts, whole genome sequences of pathogens, biomarkers for susceptibility to infection, serological panel data, and surveillance data. The Handbook of Infectious Disease Data Analysis provides an overview of many key statistical methods that have been developed in response to such new data streams and the associated ability to address key scientific and epidemiological questions. A unique feature of the Handbook is the wide range of topics covered. Key features Contributors include many leading researchers in the field Divided into four main sections: Basic concepts, Analysis of Outbreak Data, Analysis of Seroprevalence Data, Analysis of Surveillance Data Numerous case studies and examples throughout Provides both introductory material and key reference material

Handbook of Mixture Analysis

Author : Sylvia Fruhwirth-Schnatter
Publisher : CRC Press
ISBN 13 : 0429508247
Total Pages : 522 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Handbook of Mixture Analysis by : Sylvia Fruhwirth-Schnatter

Download or read book Handbook of Mixture Analysis written by Sylvia Fruhwirth-Schnatter and published by CRC Press. This book was released on 2019-01-04 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mixture models have been around for over 150 years, and they are found in many branches of statistical modelling, as a versatile and multifaceted tool. They can be applied to a wide range of data: univariate or multivariate, continuous or categorical, cross-sectional, time series, networks, and much more. Mixture analysis is a very active research topic in statistics and machine learning, with new developments in methodology and applications taking place all the time. The Handbook of Mixture Analysis is a very timely publication, presenting a broad overview of the methods and applications of this important field of research. It covers a wide array of topics, including the EM algorithm, Bayesian mixture models, model-based clustering, high-dimensional data, hidden Markov models, and applications in finance, genomics, and astronomy. Features: Provides a comprehensive overview of the methods and applications of mixture modelling and analysis Divided into three parts: Foundations and Methods; Mixture Modelling and Extensions; and Selected Applications Contains many worked examples using real data, together with computational implementation, to illustrate the methods described Includes contributions from the leading researchers in the field The Handbook of Mixture Analysis is targeted at graduate students and young researchers new to the field. It will also be an important reference for anyone working in this field, whether they are developing new methodology, or applying the models to real scientific problems.

Handbook of Meta-Analysis

Author : Christopher H. Schmid
Publisher : CRC Press
ISBN 13 : 1498703992
Total Pages : 570 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Handbook of Meta-Analysis by : Christopher H. Schmid

Download or read book Handbook of Meta-Analysis written by Christopher H. Schmid and published by CRC Press. This book was released on 2020-09-07 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: 1. Provides a comprehensive overview of meta-analysis methods and applications. 2. Divided into four major sub-topics, covering univariate meta-analysis, multivariate, applications and policy. 3. Designed to be suitable for graduate students and researchers new to the field. 4. Includes lots of real examples, with data and software code made available. 5. Chapters written by the leading researchers in the field.

Principles and Practice of Clinical Trials

Author : Steven Piantadosi
Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Clinical Trials Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470466359
Total Pages : 1247 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Clinical Trials Handbook by : Shayne Cox Gad

Download or read book Clinical Trials Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

Author : Annpey Pong
Publisher : CRC Press
ISBN 13 : 9781439810170
Total Pages : 496 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Handbook of Adaptive Designs in Pharmaceutical and Clinical Development by : Annpey Pong

Download or read book Handbook of Adaptive Designs in Pharmaceutical and Clinical Development written by Annpey Pong and published by CRC Press. This book was released on 2016-04-19 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip

Statistical Methods for Dose-Finding Experiments

Author : Sylvie Chevret
Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 344 pages
Book Rating : 4.3/5 ( download)

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Book Synopsis Statistical Methods for Dose-Finding Experiments by : Sylvie Chevret

Download or read book Statistical Methods for Dose-Finding Experiments written by Sylvie Chevret and published by John Wiley & Sons. This book was released on 2006-05-26 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dose-finding experiments define the safe dosage of a drug in development, in terms of the quantity given to a patient. Statistical methods play a crucial role in identifying optimal dosage. Used appropriately, these methods provide reliable results and reduce trial duration and costs. In practice, however, dose-finding is often done poorly, with widely used conventional methods frequently being unreliable, leading to inaccurate results. However, there have been many advances in recent years, with new statistical techniques being developed and it is important that these new techniques are utilized correctly. Statistical Methods for Dose-Finding Experiments reviews the main statistical approaches for dose-finding in phase I/II clinical trials and presents practical guidance on their correct use. Includes an introductory section, summarizing the essential concepts in dose-finding. Contains a section on algorithm-based approaches, such as the traditional 3+3 design, and a section on model-based approaches, such as the continual reassessment method. Explains fundamental issues, such as how to stop trials early and how to cope with delayed or ordinal outcomes. Discusses in detail the main websites and software used to implement the methods. Features numerous worked examples making use of real data. Statistical Methods for Dose-Finding Experiments is an important collaboration from the leading experts in the area. Primarily aimed at statisticians and clinicians working in clinical trials and medical research, there is also much to benefit graduate students of biostatistics.