Statistical Approaches In Oncology Clinical Development

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Statistical Approaches in Oncology Clinical Development

Satrajit Roychoudhury,Soumi Lahiri
Statistical Approaches in Oncology Clinical Development Book PDF

Author : Satrajit Roychoudhury,Soumi Lahiri
Publisher : CRC Press
Page : 237 pages
File Size : 40,7 Mb
Release : 2018-12-07
Category : Mathematics
ISBN : 9781498772709

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Statistical Approaches in Oncology Clinical Development by Satrajit Roychoudhury,Soumi Lahiri Pdf

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

Statistical Approaches in Oncology Clinical Development

Satrajiit Roychoudhury
Statistical Approaches in Oncology Clinical Development Book PDF

Author : Satrajiit Roychoudhury
Publisher : Unknown
Page : 400 pages
File Size : 53,7 Mb
Release : 2017
Category : MEDICAL
ISBN : 1315154439

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Statistical Approaches in Oncology Clinical Development by Satrajiit Roychoudhury Pdf

"Oncology is a rapidly developing area in medical science. A significant investment in terms of costs, resources and time is required for oncology drug development. Understanding of the challenges at all stages is vital for a successful drug launching. The purpose of this book is to provide an overview and practical solutions to some of these challenges which are commonly observed during setting up, conducting and reporting of oncology studies. This book will cover a wide variety of topics related to common challenges in cancer clinical trials across different stages of drug development."--Provided by publisher.

Handbook of Statistics in Clinical Oncology

John Crowley,Antje Hoering
Handbook of Statistics in Clinical Oncology Book PDF

Author : John Crowley,Antje Hoering
Publisher : CRC Press
Page : 643 pages
File Size : 46,8 Mb
Release : 2012-03-26
Category : Mathematics
ISBN : 9781439862018

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Handbook of Statistics in Clinical Oncology by John Crowley,Antje Hoering Pdf

Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials. Accessible to statisticians in clinical trials as well as oncologists interested in clinical trial methodology, the book presents up-to-date statistical approaches to the design and analysis of oncology clinical trials. New topics in this edition include trial designs for targeted agents, Bayesian trial design, and the inclusion of high-dimensional data and imaging techniques. This edition also contains numerous figures and examples to better explain concepts.

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 : 362 pages
File Size : 40,9 Mb
Release : 2019-03-20
Category : Mathematics
ISBN : 9781351214537

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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.

Textbook of Clinical Trials in Oncology

Susan Halabi,Stefan Michiels
Textbook of Clinical Trials in Oncology Book PDF

Author : Susan Halabi,Stefan Michiels
Publisher : CRC Press
Page : 626 pages
File Size : 54,9 Mb
Release : 2019-04-24
Category : Medical
ISBN : 9781351620970

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Textbook of Clinical Trials in Oncology by Susan Halabi,Stefan Michiels Pdf

There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Statistical Methods in Biomarker and Early Clinical Development

Liang Fang,Cheng Su
Statistical Methods in Biomarker and Early Clinical Development Book PDF

Author : Liang Fang,Cheng Su
Publisher : Springer Nature
Page : 354 pages
File Size : 50,6 Mb
Release : 2019-12-26
Category : Medical
ISBN : 9783030315030

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Statistical Methods in Biomarker and Early Clinical Development by Liang Fang,Cheng Su Pdf

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.

Introduction to Statistical Methods for Clinical Trials

Thomas D. Cook,David L. DeMets
Introduction to Statistical Methods for Clinical Trials Book PDF

Author : Thomas D. Cook,David L. DeMets
Publisher : CRC Press
Page : 452 pages
File Size : 52,7 Mb
Release : 2007-11-19
Category : Mathematics
ISBN : 9781420009965

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Introduction to Statistical Methods for Clinical Trials by Thomas D. Cook,David L. DeMets Pdf

Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors' collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various stati

Advanced Statistics in Regulatory Critical Clinical Initiatives

Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow
Advanced Statistics in Regulatory Critical Clinical Initiatives Book PDF

Author : Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow
Publisher : CRC Press
Page : 318 pages
File Size : 55,9 Mb
Release : 2022-05-25
Category : Mathematics
ISBN : 9781000567991

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Advanced Statistics in Regulatory Critical Clinical Initiatives by Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow Pdf

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Handbook of Statistics in Clinical Oncology, Second Edition

John Crowley,Antje Hoering,Donna Ankerst
Handbook of Statistics in Clinical Oncology Second Edition Book PDF

Author : John Crowley,Antje Hoering,Donna Ankerst
Publisher : Chapman and Hall/CRC
Page : 640 pages
File Size : 53,6 Mb
Release : 2005-12-01
Category : Mathematics
ISBN : 0824723392

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Handbook of Statistics in Clinical Oncology, Second Edition by John Crowley,Antje Hoering,Donna Ankerst Pdf

A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a “1⁄4good reference book for statisticians who will be designing and analyzing cancer trials." The second edition includes over 1000 references, more than forty world-renowned contributors, and 300 equations, tables, and drawings. During the five years since publication of the first edition, there has been an explosion in the technological capabilities supporting genomic and proteomic research, which are is now firmly implanted in clinical oncology. Reflecting these developments, the second edition contains a new section devoted to analyses of high-throughput data and bioinformatics. Previous chapters of the first edition have been revised to reflect current state of the art in their respective domains. The intended audience is primarily statisticians working in cancer and more generally, in any discipline of medicine. But oncologists too will find the material accessible and will benefit from a rudimentary understanding of the fundamental concepts laid forth in each chapter. Completely revised while keeping the features that made the first edition a bestseller, this is the best single source for up-to-date statistical approaches to research in clinical medicine. More than just an update of the handbook that became the gold standard, this second edition brings you fully into the genomic era of medicine.

Handbook of Statistics in Clinical Oncology

John Crowley,Antje Hoering,Donna Ankerst
Handbook of Statistics in Clinical Oncology Book PDF

Author : John Crowley,Antje Hoering,Donna Ankerst
Publisher : CRC Press
Page : 642 pages
File Size : 52,7 Mb
Release : 2005-12-01
Category : Mathematics
ISBN : 9781420027761

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Handbook of Statistics in Clinical Oncology by John Crowley,Antje Hoering,Donna Ankerst Pdf

A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a

Small Clinical Trials

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Small Clinical Trials Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 221 pages
File Size : 41,6 Mb
Release : 2001-01-01
Category : Medical
ISBN : 9780309171144

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Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Modern Clinical Trial Analysis

Wan Tang,Xin Tu
Modern Clinical Trial Analysis Book PDF

Author : Wan Tang,Xin Tu
Publisher : Springer Science & Business Media
Page : 256 pages
File Size : 43,5 Mb
Release : 2012-09-05
Category : Medical
ISBN : 9781461443223

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Modern Clinical Trial Analysis by Wan Tang,Xin Tu Pdf

This volume covers classic as well as cutting-edge topics on the analysis of clinical trial data in biomedical and psychosocial research and discusses each topic in an expository and user-friendly fashion. The intent of the book is to provide an overview of the primary statistical and data analytic issues associated with each of the selected topics, followed by a discussion of approaches for tackling such issues and available software packages for carrying out analyses. While classic topics such as survival data analysis, analysis of diagnostic test data and assessment of measurement reliability are well known and covered in depth by available topic-specific texts, this volume serves a different purpose: it provides a quick introduction to each topic for self-learning, particularly for those who have not done any formal coursework on a given topic but must learn it due to its relevance to their multidisciplinary research. In addition, the chapters on these classic topics will reflect issues particularly relevant to modern clinical trials such as longitudinal designs and new methods for analyzing data from such study designs. The coverage of these topics provides a quick introduction to these important statistical issues and methods for addressing them. As with the classic topics, this part of the volume on modern topics will enable researchers to grasp the statistical methods for addressing these emerging issues underlying modern clinical trials and to apply them to their research studies.

Statistical Methods for Survival Trial Design

Jianrong Wu
Statistical Methods for Survival Trial Design Book PDF

Author : Jianrong Wu
Publisher : CRC Press
Page : 257 pages
File Size : 51,5 Mb
Release : 2018-06-14
Category : Mathematics
ISBN : 9780429892943

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Statistical Methods for Survival Trial Design by Jianrong Wu Pdf

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

Clinical Trials in Oncology, Third Edition

Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley
Clinical Trials in Oncology Third Edition Book PDF

Author : Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley
Publisher : CRC Press
Page : 266 pages
File Size : 49,7 Mb
Release : 2012-05-09
Category : Mathematics
ISBN : 9781439814482

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Clinical Trials in Oncology, Third Edition by Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley Pdf

The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

Statistical Methods for Dose-Finding Experiments

Sylvie Chevret
Statistical Methods for Dose Finding Experiments Book PDF

Author : Sylvie Chevret
Publisher : John Wiley & Sons
Page : 344 pages
File Size : 45,8 Mb
Release : 2006-05-26
Category : Mathematics
ISBN : IND:30000121289189

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Statistical Methods for Dose-Finding Experiments by Sylvie Chevret Pdf

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.