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Agile Approach to Adaptive Research

Michael J. Rosenberg
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A01=Michael J. Rosenberg
adaptive design for clinical trials
adaptive research
Author_Michael J. Rosenberg
Category=MBGR1
Category=TDCW
clinical trials
designing clinical trials
Ekins
eq_bestseller
eq_isMigrated=1
eq_nobargain
eq_non-fiction
eq_tech-engineering
managing clinical trials
Michnael Rosenberg
Rosenberg
Sean Ekins

Product details

  • ISBN 9780470247518
  • Weight: 567g
  • Dimensions: 152 x 236mm
  • Publication Date: 05 Mar 2010
  • Publisher: John Wiley & Sons Inc
  • Publication City/Country: US
  • Product Form: Hardback
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Description
Apply adaptive research to improve results in drug development

The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently.

With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages of adaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, and demonstrates why it is an essential evolutionary step toward improving drug research and development.

Chapters explore such subjects as:

  • The adaptive concept

  • Design and operational adaptations

  • Sample-size reestimation

  • Agile clinical development

  • Safety and dose finding

  • Statistics in adaptive research, including frequentist and Bayesian approaches

  • Data management technologies

  • The future of clinical development

By combining centuries-old intellectual foundations, recent technological advances, and modern management techniques, adaptive research preserves the integrity and validity of clinical research but dramatically improves efficiency.
About Michael J. Rosenberg
MICHAEL J. ROSENBERG, MD, MPH, is President and Chief Executive Officer of Health Decisions, Inc. Involved in the design and execution of pharmaceutical development programs for more than twenty-five years, Dr. Rosenberg was selected as Entrepreneur of the Year by Ernst & Young (Health Sector, SE). His company's innovative applications of technology have been recognized by the CIO Enterprise Value Award and the Cisco Growing with Technology Award. Health Decisions has also been named three times to the Deloitte & Touche Technology Fast 500 and the Inc. 500. Dr. Rosenberg is the author of more than 150 scientific articles and serves on advisory groups in business, technology, and medicine.

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