Add free shipping to your order with these great books
Practical Considerations for Adaptive Trial Design and Implementation : Statistics for Biology and Health - Weili He

Practical Considerations for Adaptive Trial Design and Implementation

By: Weili He (Editor), Jose Pinheiro (Editor), Olga M. Kuznetsova (Editor)

Hardcover | 14 December 2014

At a Glance

Hardcover


$347.88

or 4 interest-free payments of $86.97 with

 or 

Aims to ship in 7 to 10 business days

When will this arrive by?
Enter delivery postcode to estimate

This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation.

Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.

Industry Reviews

From the book reviews:

"The target audience is anyone with an interest in planning and executing clinical trials. This includes statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers working in academic research organizations, government, or industry. ... This is a high quality book, written by contributors who are authorities in the field of adaptive trial design. It is an excellent addition to this field and fills a significant void." (Ashraf Khaled AbuSara, Doody's Book Reviews, January, 2015)

Other Editions and Formats

Paperback

Published: 22nd September 2016

More in Epidemiology & Medical Statistics

Oxford Handbook of Clinical Medicine : Oxford Medical Handbooks - Ian B. Wilkinson
Public Health : 3rd Edition - Local and Global Perspectives - Pranee Liamputtong
Essentials of Medical Statistics : 2nd Edition - Betty R. Kirkwood

RRP $91.95

$59.90

35%
OFF
Introduction to Medical Statistics : 4th edition - Martin Bland

RRP $70.95

$62.35

12%
OFF
Modern Epidemiology : 4th Edition - Kenneth J. Rothman

RRP $203.00

$157.75

22%
OFF
Oxford Handbook of Public Health Practice : 4th Edition - Ichiro Kawachi
Essentials of Biostatistics in Public Health : 4th Edition - Lisa M. Sullivan
Clinical Epidemiology : 6th Edition - The Essentials - Grant S. Fletcher
Parasitology : 2nd Edition - A Conceptual Approach - Bruce V.  Hofkin

RRP $204.00

$163.25

20%
OFF
Gordis Epidemiology : 7th Edition - David D, ScD, MHS  Celentano
Infectious Disease Epidemiology : An Introduction - Eyal Oren

RRP $127.00

$114.50

10%
OFF
Epidemiology : A Very Short Introduction - Rodolfo Saracci

RRP $165.00

$145.50

12%
OFF
Study Guide to Epidemiology and Biostatistics : 7th Edition - J. Richard Hebel
Foundations Of Infection Control And Prevention - Christine Mcguire-Wolfe

RRP $195.75

$167.75

14%
OFF
Essentials of Epidemiology in Public Health - Ann Aschengrau

RRP $199.50

$118.50

41%
OFF