Health Decisions CEO Michael Rosenberg authors an in-depth review of progressive research in new interdisciplinary manual
Durham, NC: August 12, 2009
Michael Rosenberg, CEO of Health Decisions and founder of the CRO’s Agile Clinical Development methodology, authors an instructional guide to adaptive research best practices in John Wiley and Son’s comprehensive new Clinical Trials Handbook. According to Rosenberg, these adaptive techniques are vital to reforming the drug development industry in preparation for forecasted market challenges.
- How to enhance strategic trial design with adaptive methods such as dose finding, sample size re-estimation (SSRE), randomization, and seamless transition between phases
- The often-overlooked impact of applying adaptive methods to trial operations
- How adaptive techniques can mitigate the largest and most common sources of inefficiency in clinical research: enrollment, monitoring, query management and database lock
- Implementation issues encountered by adaptive programs, including procedural, structural, technological and regulatory components
Clinical Trials Handbook description:
- Weaves together contributions from a range of interdisciplinary experts
- Edited by Shayne Cox Gad of Gad Consulting Services
- Thoroughly covers “the most important steps in proving a drug effective and safe for public use.” — Wiley
- Comprehensive scope and detailed level of examination
- A valuable resource for clinical researchers of all experience levels, whether their objective is to master the basics of trial management or to improve procedures based on current best practices
- Available through both Wiley and Research and Markets
Following on the heels of his contribution to Clinical Trials Handbook, Rosenberg is planning to release a full-length book examining the newest and most effective tactics in adaptive research. Titled The Agile Approach to Adaptive Research – Optimizing Efficiency in Clinical Development, the book is slated for publication early next year also by Wiley and Sons.
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“Adaptive methods must be recognized as a foundational element if we’re going to successfully raise the bar for clinical research efficiency. This section in Wiley’s new handbook is a complete description of the principles that I’ve seen benefit sponsors with dramatic time-savings during my twenty years of experience, regardless of program size, complexity or therapeutic area.”
Contributing author of Clinical Trials Handbook