Novel Designs of Early Phase Trials for Cancer Therapeutics

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  • Publisher : Academic Press
  • Release : 22 May 2018
  • ISBN : 9780128125700
  • Page : 234 pages
  • Rating : 4.5/5 from 103 voters

Novel Designs of Early Phase Trials for Cancer Therapeutics Book PDF summary

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

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Novel Designs of Early Phase Trials for Cancer Therapeutics

Novel Designs of Early Phase Trials for Cancer Therapeutics
  • Author : Shivaani Kummar,Chris Takimoto
  • Publisher : Academic Press
  • Release Date : 2018-05-22
  • ISBN : 9780128125700
DOWNLOAD BOOKNovel Designs of Early Phase Trials for Cancer Therapeutics

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

Phase I Oncology Drug Development

Phase I Oncology Drug Development
  • Author : Timothy A. Yap,Jordi Rodon,David S. Hong
  • Publisher : Springer Nature
  • Release Date : 2020-09-16
  • ISBN : 9783030476823
DOWNLOAD BOOKPhase I Oncology Drug Development

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

Phase I Cancer Clinical Trials

Phase I Cancer Clinical Trials
  • Author : Chris Twelves,Marc E. Buyse
  • Publisher : Oxford University Press, USA
  • Release Date : 2014-06-01
  • ISBN : 9780199359011
DOWNLOAD BOOKPhase I Cancer Clinical Trials

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

Bayesian Designs for Phase I-II Clinical Trials

Bayesian Designs for Phase I-II Clinical Trials
  • Author : Ying Yuan,Hoang Q. Nguyen,Peter F. Thall
  • Publisher : CRC Press
  • Release Date : 2017-12-19
  • ISBN : 9781498709569
DOWNLOAD BOOKBayesian Designs for Phase I-II Clinical Trials

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

Statistical Approaches in Oncology Clinical Development

Statistical Approaches in Oncology Clinical Development
  • Author : Satrajit Roychoudhury,Soumi Lahiri
  • Publisher : CRC Press
  • Release Date : 2018-12-07
  • ISBN : 9781351650472
DOWNLOAD BOOKStatistical Approaches in Oncology Clinical Development

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

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher : National Academies Press
  • Release Date : 2010-10-22
  • ISBN : 0309163358
DOWNLOAD BOOKTransforming Clinical Research in the United States

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is

Clinical Trials

Clinical Trials
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release Date : 2016-02-19
  • ISBN : 9780128042588
DOWNLOAD BOOKClinical Trials

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual

Small Clinical Trials

Small Clinical Trials
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
  • Publisher : National Academies Press
  • Release Date : 2001-01-01
  • ISBN : 0309171148
DOWNLOAD BOOKSmall Clinical Trials

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