Health Decisions Contributes Adaptive Research Best Practices to Wiley’s "Clinical Trials Handbook"
CEO Michael Rosenberg authors an in-depth review of progressive research in new interdisciplinary manual
Durham, NC, August 15, 2009 --(PR.com)-- 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.
For more information, please contact Katie Hendrick by email at khendrick@healthdec.com or by phone at +1.919.967.1111 x116.
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.
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.
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.
###
“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.
For more information, please contact Katie Hendrick by email at khendrick@healthdec.com or by phone at +1.919.967.1111 x116.
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.
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.
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.
###
Contact
Health Decisions
Katie Hendrick
919-960-1111x116
www.HealthDec.com
Katie Hendrick
919-960-1111x116
www.HealthDec.com
Contact
Categories