Adaptive Research Essentials Are Brought to Light in Wiley’s Clinical Trials Handbook

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.

Clinical_Trials_HandbookKey topics from Rosenberg’s chapter, “Adaptive Research:”
  • 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.

For more information, contact Courtney Cleaves, Marketing Manager at ccleaves@healthdec.com.

About Wiley
Founded in 1807, John Wiley & Sons, Inc. has been a valued source of information and understanding for more than 200 years; helping people around the world meet their needs and fulfill their aspirations. Wiley and its acquired companies have published the works of more than 350 Nobel laureates in all categories: Literature, Economics, Physiology/Medicine, Physics, Chemistry, and Peace.

Wiley’s core businesses include scientific, technical, medical, and scholarly journals, encyclopedias, books, and online products and services; professional/trade books, subscription products, training materials and online applications and Web sites; and educational materials for undergraduate and graduate students and lifelong learners. Wiley’s global headquarters are located in Hoboken, New Jersey, with operations in the US, Europe, Asia, Canada, and Australia. The Company’s Web site can be accessed at www.wiley.com. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb.

Michael Rosenberg“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.”

Michael Rosenberg
CEO
Health Decisions
Contributing author of Clinical Trials Handbook

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