Health Decisions Contributes Adaptive Research Best Practices to Wiley's "Clinical Trials Handbook"
Michael Rosenberg, CEO of Health Decisions and founder of the CRO's Agile Clinical Development methodology http://www.healthdec.com/page/what-is-agile), presents an instructional guide to adaptive research best practices in John Wiley and Son's comprehensive new "Clinical Trials Handbook" (http://www.wiley.com/WileyCDA/WileyTitle/productCd-0471213888.html). According to Rosenberg, these adaptive techniques are vital to reforming the drug development industry in preparation for forecasted market challenges.
"Adaptive methods must be recognized as a foundational element if we're going to successfully raise the bar for clinical research efficiency," he said. "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."
Topics from Rosenberg's chapter, "Adaptive Research," include:
* 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
The book, which is edited by Shayne Cox Gad of Gad Consulting Services, weaves together contributions from a range of interdisciplinary experts, thoroughly covering "the most important steps in proving a drug effective and safe for public use," according to Wiley's press material. Given its comprehensive scope and detailed level of examination, the edition is 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. "Clinical Trials Handbook" is available through both Wiley (www.wiley.com/WileyCDA/WileyTitle/productCd-0471213888.html) and Research and Markets (www.researchandmarkets.com/reportinfo.asp?report_id=1054061&t=d&cat_id=).
Health Decisions is also giving away free copies through a weekly drawing now through September 4. To enter, visit www.healthdec.com/page/free-clinical-trials-handbook.
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.
About Michael Rosenberg, contributing author to "Clinical Trial Handbook"
Dr. Michael Rosenberg has been active in clinical research for more than 30 years, designing and conducting worldwide studies in a range of therapeutic areas. Early in his career, Michael realized that excellence in clinical research requires elevating managerial standards to the same high level as scientific standards. He founded Health Decisions in 1989 to develop a more efficient approach to managing clinical trials. For more information, visit Michael's full bio at http://www.healthdec.com/page/president-ceo-michael-rosenberg-md.
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About Health Decisions
Health Decisions (www.HealthDec.com), a global clinical research organization (CRO), leads the industry in trial efficiency. Through integrated technology and agile clinical development methods that apply adaptive principles to both trial design and operations, Health Decisions provides sponsors unprecedented transparency and control and produces results 10-40 percent faster than traditional approaches.
Health Decisions is headquartered in Durham, NC, with over twenty years of drug development experience in setting new standards of speed and accuracy for pharmaceutical, biotech and medical device companies in Phase I-IV trials across all major therapy areas.