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Why You Should Be Adopting Adaptive Trials



By Kevin Davies

September 20, 2012 | A special one-day conference next month will showcase many of the leading figures in the emerging field of adaptive trial designs, with a view to helping organizations recognize their benefits and understand the keys to successful implementation.

The event—Transforming Drug Development: Delivering Innovation and Efficiency through Clinical Trialswill be held on October 22 at the Bethesda Marriott Hotel in Bethesda, Maryland. It is being sponsored by three partnering organizations—Aptiv Solutions, Berry Consultants, and Tessella—and being co-organized by (eCliniqua parent company) Cambridge Healthtech Institute.

There have been some impressive advances in the design and conduct of adaptive clinical trials in recent years, saving time during clinical trials, significant sums of money, and facilitating inter-company trials. The ultimate goal, of course, is to increase the likelihood of bringing beneficial therapies to market, although the advent of adaptive designs is probably too recent to allow many proven examples of the process to be given.

The Transforming Drug Development conference is designed to provide attendees with a better understanding of the promise of adaptive trials and the required organizational steps and changes required to implement them.

The organizers have pulled together an impressive line-up of industry speakers familiar with the economics and management of drug development and clinical trials; the statistical design of adaptive trials; and the implementation and execution of adaptive designs. Among the many distinguished speakers are:

·         Kenneth Getz (Senior Research Fellow, Director of Sponsored Programs, Tufts CSDD)—a leading commentator on the optimal design and execution of clinical trials

·         Don Berry (Professor of Biostatistics, University of Texas MD Anderson Cancer Center)—co-founder with his son Scott Berry (also speaking) of Berry Consultants, a leading consulting firm that specializes in Bayesian statistics and adaptive trial designs

·         Mike Krams (VP & Head, Neurology Franchise, Johnson & Johnson)—one of the most experienced big pharma executives in running successful adaptive trials, as he previously discussed in an in-depth interview in 2007 with Bio-IT World while working at Wyeth.

·         Steve Arlington (Global Advisory Leader, Pharmaceuticals and Life Sciences, PwC)—leader of the global advisory team at PwC with nearly two decades of experience, focused on the pharmaceutical and life sciences industry

·         Scott Gottlieb (Research Fellow, American Enterprise Institute) – high-profile former deputy commissioner for medical and scientific affairs at the FDA.

·         Tom Parke (Head Clinical Trial Solutions, Tessella) and Vlad Dragalin (Senior VP, Innovation Center, Aptiv Solutions) will lend their perspectives on adaptive trial best practices.

The price to register for the conference is just $145 for registration before September 21, thereafter $195. To see the agenda and register, visit: http://www.innovationsinclinicaltrials.com/

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