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Phase I Cancer Clinical Trials

2014-06 Language Arts & Disciplines
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Release : 2014-06
Genre : Language Arts & Disciplines
Kind : eBook
Book Rating : 016/5 ( reviews)

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Book Synopsis Phase I Cancer Clinical Trials by : Elizabeth A. Eisenhauer

Download or read book Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer. This book was released on 2014-06. Available in PDF, EPUB and Kindle. Book excerpt: Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it 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.

Dose-Finding Designs for Early-Phase Cancer Clinical Trials

2019-05-21 Medical
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Release : 2019-05-21
Genre : Medical
Kind : eBook
Book Rating : 854/5 ( reviews)

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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. This book was released on 2019-05-21. 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.

Novel Designs of Early Phase Trials for Cancer Therapeutics

2018-05-22 Medical
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Release : 2018-05-22
Genre : Medical
Kind : eBook
Book Rating : 705/5 ( reviews)

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Book Synopsis Novel Designs of Early Phase Trials for Cancer Therapeutics by : Shivaani Kummar

Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar. This book was released on 2018-05-22. Available in PDF, EPUB and Kindle. Book excerpt: 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

Clinical Trials in Oncology, Third Edition

2012-05-09 Mathematics
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Release : 2012-05-09
Genre : Mathematics
Kind : eBook
Book Rating : 481/5 ( reviews)

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Book Synopsis Clinical Trials in Oncology, Third Edition by : Stephanie Green

Download or read book Clinical Trials in Oncology, Third Edition written by Stephanie Green. This book was released on 2012-05-09. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Phase I Oncology Drug Development

2020-09-16 Medical
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Release : 2020-09-16
Genre : Medical
Kind : eBook
Book Rating : 820/5 ( reviews)

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Book Synopsis Phase I Oncology Drug Development by : Timothy A. Yap

Download or read book Phase I Oncology Drug Development written by Timothy A. Yap. This book was released on 2020-09-16. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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