Phase I Cancer Clinical Trials

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Phase I Cancer Clinical Trials


Phase I Cancer Clinical Trials
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Phase I Cancer Clinical Trials


Phase I Cancer Clinical Trials
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Author : Chris Twelves
language : en
Publisher: Oxford University Press, USA
Release Date : 2014-06-01

Phase I Cancer Clinical Trials written by Chris Twelves and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-06-01 with Medical categories.


Preceded by Phase I cancer clinical trials: a practical guide / Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse. 1st ed. 2006.

Phase I Cancer Clinical Trials


Phase I Cancer Clinical Trials
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Author : Elizabeth A. Eisenhauer
language : en
Publisher: Oxford University Press
Release Date : 2015-03-20

Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-03-20 with Medical categories.


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

Bayesian Designs For Phase I Ii Clinical Trials


Bayesian Designs For Phase I Ii Clinical Trials
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Author : Ying Yuan
language : en
Publisher: CRC Press
Release Date : 2017-12-19

Bayesian Designs For Phase I Ii Clinical Trials written by Ying Yuan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-19 with Mathematics categories.


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.

Clinical Trials In Oncology Third Edition


Clinical Trials In Oncology Third Edition
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Author : Stephanie Green
language : en
Publisher: CRC Press
Release Date : 2012-05-09

Clinical Trials In Oncology Third Edition written by Stephanie Green and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-09 with Mathematics categories.


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.

Novel Designs Of Early Phase Trials For Cancer Therapeutics


Novel Designs Of Early Phase Trials For Cancer Therapeutics
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Author : Shivaani Kummar
language : en
Publisher: Academic Press
Release Date : 2018-05-22

Novel Designs Of Early Phase Trials For Cancer Therapeutics written by Shivaani Kummar and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-22 with Medical categories.


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

Dose Finding Designs For Early Phase Cancer Clinical Trials


Dose Finding Designs For Early Phase Cancer Clinical Trials
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Author : Takashi Daimon
language : en
Publisher: Springer
Release Date : 2019-05-21

Dose Finding Designs For Early Phase Cancer Clinical Trials written by Takashi Daimon and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-21 with Medical categories.


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.

Evaluation Of Phase I Designs For Use In Cancer Clinical Trials


Evaluation Of Phase I Designs For Use In Cancer Clinical Trials
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Author : Sherryl A. Baker
language : en
Publisher:
Release Date : 1992

Evaluation Of Phase I Designs For Use In Cancer Clinical Trials written by Sherryl A. Baker and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Antineoplastic agents categories.