Novel 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 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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  • Author : Shivaani Kummar
  • Publisher : Academic Press
  • Pages : 234 pages
  • ISBN : 0128125705
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKNovel Designs of Early Phase Trials for Cancer Therapeutics

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 : 22 May 2018
GET THIS 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

Drug Discovery and Development

Drug Discovery and Development
  • Author : Omboon Vallisuta,Suleiman Olimat
  • Publisher : BoD – Books on Demand
  • Release : 03 June 2015
GET THIS BOOKDrug Discovery and Development

It is very important for scientists all over the globe to enhance drug discovery research for better human health. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. The following 5 sections cover diverse chapter topics in drug discovery: Natural Products as Sources of Leading Molecules in Drug Discovery; Oncology and Drug Discovery; Receptors Involvement in Drug Discovery; Management and Development of Drugs against

Blood and Marrow Transplantation Long Term Management

Blood and Marrow Transplantation Long Term Management
  • Author : Bipin N. Savani,Andre Tichelli
  • Publisher : John Wiley & Sons
  • Release : 02 March 2021
GET THIS BOOKBlood and Marrow Transplantation Long Term Management

Hematopoietic cell transplantation (HCT) provides curative therapy for a variety of diseases. Over the past several decades, significant advances have been made in the field of HCT, to the point where HCT has become an integral part of treatment modality for a variety of hematologic malignancies and some nonmalignant diseases. HCT remains an important treatment option for a wide variety of hematologic and nonhematologic disorders, despite recent advances in the field of immunologic therapies. Factors driving this growth include expanded

Oncology Clinical Trials

Oncology Clinical Trials
  • Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
  • Publisher : Demos Medical Publishing
  • Release : 22 December 2009
GET THIS BOOKOncology Clinical Trials

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial

A National Cancer Clinical Trials System for the 21st Century

A National Cancer Clinical Trials System for the 21st Century
  • Author : Institute of Medicine,Board on Health Care Services,Committee on Cancer Clinical Trials and the NCI Cooperative Group Program
  • Publisher : National Academies Press
  • Release : 08 July 2010
GET THIS BOOKA National Cancer Clinical Trials System for the 21st Century

The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

Statistical Approaches in Oncology Clinical Development

Statistical Approaches in Oncology Clinical Development
  • Author : Satrajit Roychoudhury,Soumi Lahiri
  • Publisher : CRC Press
  • Release : 07 December 2018
GET THIS 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

Phase I Cancer Clinical Trials

Phase I Cancer Clinical Trials
  • Author : Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse
  • Publisher : Oxford University Press
  • Release : 20 March 2015
GET THIS BOOKPhase I Cancer Clinical Trials

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

The Drug Development Paradigm in Oncology

The Drug Development Paradigm in Oncology
  • 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
  • Release : 12 March 2018
GET THIS BOOKThe Drug Development Paradigm in Oncology

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

Handbook of Statistics in Clinical Oncology, Third Edition

Handbook of Statistics in Clinical Oncology, Third Edition
  • Author : John Crowley,Antje Hoering
  • Publisher : CRC Press
  • Release : 26 March 2012
GET THIS BOOKHandbook of Statistics in Clinical Oncology, Third Edition

Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics

A Practical Guide to Designing Phase II Trials in Oncology

A Practical Guide to Designing Phase II Trials in Oncology
  • Author : Sarah R. Brown,Walter M. Gregory,Christopher J. Twelves,Julia M. Brown
  • Publisher : John Wiley & Sons
  • Release : 28 March 2014
GET THIS BOOKA Practical Guide to Designing Phase II Trials in Oncology

How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available

Phase I Oncology Drug Development

Phase I Oncology Drug Development
  • Author : Timothy A. Yap,Jordi Rodon,David S. Hong
  • Publisher : Springer Nature
  • Release : 18 October 2020
GET THIS 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

Cancer Clinical Trials

Cancer Clinical Trials
  • Author : Stephen L. George,Xiaofei Wang,Herbert Pang
  • Publisher : CRC Press
  • Release : 19 August 2016
GET THIS BOOKCancer Clinical Trials

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of

Clinical Trials

Clinical Trials
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release : 25 October 2011
GET THIS BOOKClinical Trials

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial