Modern Dose Finding Designs For Cancer Phase I Trials Drug Combinations And Molecularly Targeted Agents

Modern Dose Finding Designs For Cancer Phase I Trials Drug Combinations And Molecularly Targeted Agents Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Modern Dose Finding Designs For Cancer Phase I Trials Drug Combinations And Molecularly Targeted Agents book. This book definitely worth reading, it is an incredibly well-written.

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

Akihiro Hirakawa,Hiroyuki Sato,Takashi Daimon,Shigeyuki Matsui
Modern Dose Finding Designs for Cancer Phase I Trials Drug Combinations and Molecularly Targeted Agents Book PDF

Author : Akihiro Hirakawa,Hiroyuki Sato,Takashi Daimon,Shigeyuki Matsui
Publisher : Springer
Page : 100 pages
File Size : 51,5 Mb
Release : 2018-01-30
Category : Medical
ISBN : 9784431555735

Get Book

Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents by Akihiro Hirakawa,Hiroyuki Sato,Takashi Daimon,Shigeyuki Matsui Pdf

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.

Dose-Finding Designs for Early-Phase Cancer Clinical Trials

Takashi Daimon,Akihiro Hirakawa,Shigeyuki Matsui
Dose Finding Designs for Early Phase Cancer Clinical Trials Book PDF

Author : Takashi Daimon,Akihiro Hirakawa,Shigeyuki Matsui
Publisher : Springer
Page : 133 pages
File Size : 42,7 Mb
Release : 2019-05-21
Category : Medical
ISBN : 9784431555858

Get Book

Dose-Finding Designs for Early-Phase Cancer Clinical Trials by Takashi Daimon,Akihiro Hirakawa,Shigeyuki Matsui Pdf

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.

Novel Designs of Early Phase Trials for Cancer Therapeutics

Shivaani Kummar,Chris Takimoto
Novel Designs of Early Phase Trials for Cancer Therapeutics Book PDF

Author : Shivaani Kummar,Chris Takimoto
Publisher : Academic Press
Page : 234 pages
File Size : 54,6 Mb
Release : 2018-05-22
Category : Medical
ISBN : 9780128125700

Get Book

Novel Designs of Early Phase Trials for Cancer Therapeutics by Shivaani Kummar,Chris Takimoto Pdf

Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

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

John O'Quigley,Alexia Iasonos,Björn Bornkamp
Handbook of Methods for Designing Monitoring and Analyzing Dose Finding Trials Book PDF

Author : John O'Quigley,Alexia Iasonos,Björn Bornkamp
Publisher : CRC Press
Page : 306 pages
File Size : 49,5 Mb
Release : 2017-04-27
Category : Mathematics
ISBN : 9781498746113

Get Book

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials by John O'Quigley,Alexia Iasonos,Björn Bornkamp Pdf

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.

Phase I Oncology Drug Development

Timothy A. Yap,Jordi Rodon,David S. Hong
Phase I Oncology Drug Development Book PDF

Author : Timothy A. Yap,Jordi Rodon,David S. Hong
Publisher : Springer Nature
Page : 352 pages
File Size : 53,8 Mb
Release : 2020-09-16
Category : Medical
ISBN : 9783030476823

Get Book

Phase I Oncology Drug Development by Timothy A. Yap,Jordi Rodon,David S. Hong Pdf

This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.

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

John O'Quigley,Alexia Iasonos,Björn Bornkamp
Handbook of Methods for Designing Monitoring and Analyzing Dose Finding Trials Book PDF

Author : John O'Quigley,Alexia Iasonos,Björn Bornkamp
Publisher : CRC Press
Page : 410 pages
File Size : 50,8 Mb
Release : 2017-04-27
Category : Mathematics
ISBN : 9781351648028

Get Book

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials by John O'Quigley,Alexia Iasonos,Björn Bornkamp Pdf

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.

Principles and Practice of Clinical Trials

Steven Piantadosi,Curtis L. Meinert
Principles and Practice of Clinical Trials Book PDF

Author : Steven Piantadosi,Curtis L. Meinert
Publisher : Springer Nature
Page : 2573 pages
File Size : 49,9 Mb
Release : 2022-07-19
Category : Medical
ISBN : 9783319526362

Get Book

Principles and Practice of Clinical Trials by Steven Piantadosi,Curtis L. Meinert Pdf

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.

Phase I Cancer Clinical Trials

Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse
Phase I Cancer Clinical Trials Book PDF

Author : Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse
Publisher : Oxford University Press
Page : 352 pages
File Size : 45,6 Mb
Release : 2015-03-20
Category : Medical
ISBN : 9780199359035

Get Book

Phase I Cancer Clinical Trials by Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse Pdf

Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials

Statistical Methods in Drug Combination Studies

Wei Zhao,Harry Yang
Statistical Methods in Drug Combination Studies Book PDF

Author : Wei Zhao,Harry Yang
Publisher : CRC Press
Page : 236 pages
File Size : 41,5 Mb
Release : 2014-12-19
Category : Mathematics
ISBN : 9781482216752

Get Book

Statistical Methods in Drug Combination Studies by Wei Zhao,Harry Yang Pdf

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve

Modern Statistical Methods for Health Research

Yichuan Zhao,(Din) Ding-Geng Chen
Modern Statistical Methods for Health Research Book PDF

Author : Yichuan Zhao,(Din) Ding-Geng Chen
Publisher : Springer Nature
Page : 506 pages
File Size : 54,8 Mb
Release : 2021-10-14
Category : Medical
ISBN : 9783030724375

Get Book

Modern Statistical Methods for Health Research by Yichuan Zhao,(Din) Ding-Geng Chen Pdf

This book brings together the voices of leading experts in the frontiers of biostatistics, biomedicine, and the health sciences to discuss the statistical procedures, useful methods, and novel applications in biostatistics research. It also includes discussions of potential future directions of biomedicine and new statistical developments for health research, with the intent of stimulating research and fostering the interactions of scholars across health research related disciplines. Topics covered include: Health data analysis and applications to EHR data Clinical trials, FDR, and applications in health science Big network analytics and its applications in GWAS Survival analysis and functional data analysis Graphical modelling in genomic studies The book will be valuable to data scientists and statisticians who are working in biomedicine and health, other practitioners in the health sciences, and graduate students and researchers in biostatistics and health.

The Drug Development Paradigm in Oncology

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
The Drug Development Paradigm in Oncology Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
Publisher : National Academies Press
Page : 145 pages
File Size : 48,6 Mb
Release : 2018-02-12
Category : Medical
ISBN : 9780309457972

Get Book

The Drug Development Paradigm in Oncology by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum Pdf

Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Bayesian Designs for Phase I-II Clinical Trials

Ying Yuan,Hoang Q. Nguyen,Peter F. Thall
Bayesian Designs for Phase I II Clinical Trials Book PDF

Author : Ying Yuan,Hoang Q. Nguyen,Peter F. Thall
Publisher : CRC Press
Page : 233 pages
File Size : 43,6 Mb
Release : 2017-12-19
Category : Mathematics
ISBN : 9781315354224

Get Book

Bayesian Designs for Phase I-II Clinical Trials by Ying Yuan,Hoang Q. Nguyen,Peter F. Thall Pdf

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

Dose Finding by the Continual Reassessment Method

Ying Kuen Cheung
Dose Finding by the Continual Reassessment Method Book PDF

Author : Ying Kuen Cheung
Publisher : CRC Press
Page : 207 pages
File Size : 40,8 Mb
Release : 2011-03-29
Category : Mathematics
ISBN : 9781420091519

Get Book

Dose Finding by the Continual Reassessment Method by Ying Kuen Cheung Pdf

As clinicians begin to realize the important role of dose-finding in the drug development process, there is an increasing openness to "novel" methods proposed in the past two decades. In particular, the Continual Reassessment Method (CRM) and its variations have drawn much attention in the medical community, though it has yet to become a commonplace tool. To overcome the status quo in phase I clinical trials, statisticians must be able to design trials using the CRM in a timely and reproducible manner. A self-contained theoretical framework of the CRM for researchers and graduate students who set out to learn and do research in the CRM and dose-finding methods in general, Dose Finding by the Continual Reassessment Method features: Real clinical trial examples that illustrate the methods and techniques throughout the book Detailed calibration techniques that enable biostatisticians to design a CRM in timely manner Limitations of the CRM are outlined to aid in correct use of method This book supplies practical, efficient dose-finding methods based on cutting edge statistical research. More than just a cookbook, it provides full, unified coverage of the CRM in addition to step-by-step guidelines to automation and parameterization of the methods used on a regular basis. A detailed exposition of the calibration of the CRM for applied statisticians working with dose-finding in phase I trials, the book focuses on the R package ‘dfcrm’ for the CRM and its major variants. The author recognizes clinicians’ skepticism of model-based designs, and addresses their concerns that the time, professional, and computational resources necessary for accurate model-based designs can be major bottlenecks to the widespread use of appropriate dose-finding methods in phase I practice. The theoretically- and empirically-based methods in Dose Finding by the Continual Reassessment Method will lessen the statistician’s burden and encourage the continuing development and implementation of model-based dose-finding methods.

Model-Assisted Bayesian Designs for Dose Finding and Optimization

Ying Yuan,Ruitao Lin,J. Jack Lee
Model Assisted Bayesian Designs for Dose Finding and Optimization Book PDF

Author : Ying Yuan,Ruitao Lin,J. Jack Lee
Publisher : CRC Press
Page : 239 pages
File Size : 48,6 Mb
Release : 2022-11-11
Category : Medical
ISBN : 9780429626838

Get Book

Model-Assisted Bayesian Designs for Dose Finding and Optimization by Ying Yuan,Ruitao Lin,J. Jack Lee Pdf

Bayesian adaptive designs provide a critical approach to improve the efficiency and success of drug development that has been embraced by the US Food and Drug Administration (FDA). This is particularly important for early phase trials as they form the basis for the development and success of subsequent phase II and III trials. The objective of this book is to describe the state-of-the-art model-assisted designs to facilitate and accelerate the use of novel adaptive designs for early phase clinical trials. Model-assisted designs possess avant-garde features where superiority meets simplicity. Model-assisted designs enjoy exceptional performance comparable to more complicated model-based adaptive designs, yet their decision rules often can be pre-tabulated and included in the protocol—making implementation as simple as conventional algorithm-based designs. An example is the Bayesian optimal interval (BOIN) design, the first dose-finding design to receive the fit-for-purpose designation from the FDA. This designation underscores the regulatory agency's support of the use of the novel adaptive design to improve drug development. Features Represents the first book to provide comprehensive coverage of model-assisted designs for various types of dose-finding and optimization clinical trials Describes the up-to-date theory and practice for model-assisted designs Presents many practical challenges, issues, and solutions arising from early-phase clinical trials Illustrates with many real trial applications Offers numerous tips and guidance on designing dose finding and optimization trials Provides step-by-step illustrations of using software to design trials Develops a companion website (www.trialdesign.org) to provide freely available, easy-to-use software to assist learning and implementing model-assisted designs Written by internationally recognized research leaders who pioneered model-assisted designs from the University of Texas MD Anderson Cancer Center, this book shows how model-assisted designs can greatly improve the efficiency and simplify the design, conduct, and optimization of early-phase dose-finding trials. It should therefore be a very useful practical reference for biostatisticians, clinicians working in clinical trials, and drug regulatory professionals, as well as graduate students of biostatistics. Novel model-assisted designs showcase the new KISS principle: Keep it simple and smart!

Metronomic Chemotherapy

Guido Bocci,Giulio Francia
Metronomic Chemotherapy Book PDF

Author : Guido Bocci,Giulio Francia
Publisher : Springer
Page : 302 pages
File Size : 40,6 Mb
Release : 2014-09-04
Category : Medical
ISBN : 9783662436042

Get Book

Metronomic Chemotherapy by Guido Bocci,Giulio Francia Pdf

This book analyzes all aspects of metronomic chemotherapy, a new approach involving low-dose, long-term, and frequently administered therapy that has preclinical and clinical activity in various tumors. After an opening section on the pharmacological bases of metronomic chemotherapy, including its antiangiogenic effects and impact on immunity, preclinical studies on various classes of drug are discussed. Clinical applications of metronomic chemotherapy in a wide variety of tumors are then addressed in detail, with description of the results of all published studies. The clinical pharmacology of metronomic chemotherapy is also considered in depth, encompassing pharmacokinetics, pharmacogenetics, pharmacoeconomics, and adverse drug reactions. The book closes by describing the role of this therapy in the veterinarian clinic.