Rosenberg The Agile Approach to Adaptive Research

Optimizing Efficiency in Clinical Development
1. Auflage 2010
ISBN: 978-0-470-59967-9
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 304 Seiten, E-Book

Reihe: Wiley Series on Technologies for the Pharmaceutical

Apply adaptive research to improve results in drugdevelopment
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 toolsand techniques, can enable the industry to streamline clinicaltrials and reach decision points faster and more efficiently.
With a wealth of real-world cases and examples, author MichaelRosenberg gives readers a practical overview of drug development,the problems inherent in current practices, and the advantages ofadaptive research technology and methods. He explains the concepts,principles, and specific techniques of adaptive research, anddemonstrates why it is an essential evolutionary step towardimproving 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 andBayesian approaches
* Data management technologies
* The future of clinical development
By combining centuries-old intellectual foundations, recenttechnological advances, and modern management techniques, adaptiveresearch preserves the integrity and validity of clinical researchbut dramatically improves efficiency.

Autoren/Hrsg.

Rosenberg, Michael J.

Weitere Mitwirkende

Ekins, Sean

Über Autor(innen)

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.