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Audio conference highlights

Adaptive methods are increasingly used for statistical issues in research, but this limited use overlooks the most powerful and sustained advantages: application of the same adaptive principles to how a study is run. This approach focuses on continuous measurement and refinement of key study metrics that include rapid enrollment, reduced waste, lowering monitoring costs, and quick study conclusion and database lock. Compared to traditional approaches, adaptive methods typically enable 20% faster enrollment, 20-80% lower study query rates, 20-60% lower monitoring costs, and 50% faster database locks.

This audio conference will discuss the tools and processes essential to this approach, along with design and planning issues and net financial impact on Net Present Value and Internal Rate of Return.

This audio conference covers:

• How adaptive methods can improve R&D efficiency.
• The overlooked operational component of adaptive clinical trials.
• Pragmatic considerations for adaptive clinical trials.
• Essential tools, considerations, design and planning measures for the adaptive approach.

About the speaker:

Michael Rosenberg, M.D., Ph. D. has been involved with the strategic design and execution of pharmaceutical development programs for more than 25 years. He is President and CEO of Health Decisions, Inc., a leader in the application of technology to improve the efficiency of the clinical research process. Health Decisions has won numerous awards for growth and innovative technology, and Dr. Rosenberg was selected as Ernst and Young’s Entrepreneur of the Year in 2000. Dr. Rosenberg practices emergency medicine part time and serves as Clinical Professor of Obstetrics and Gynecology and of Epidemiology at the University of North Carolina.

The author of more than a hundred and fifty scientific articles, his professional achievements have been recognized by Fellowship in the American College of Physicians, American College of Preventive Medicine, and the American College of Epidemiology. Dr. Rosenberg received his undergraduate and medical degrees from the University of California and a Master’s degree in Epidemiology and Biostatistics from Harvard University.

Who should attend?

• C-Suite
• Directors of Clinical and Data Management
• R&D VPs and Executives
• Clinical Trial Managers
• Health Sciences Venture Capitalists

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.