NIH and FDA announce awards to advance regulatory science

“We are excited about a new grant award from NIH and FDA, joint with the University of Michigan, to explore adaptive designs in the NETT trials.  Don Berry and Roger Lewis, representing Berry Consultants, and Bill Barsan from the University of Michigan are PIs on the award.  We will be working closely with the design teams for 4-5 separate trials to look at creating more efficient designs.  We will be interacting with the study teams, regulators, and implementation teams to explore the efficiencies possible with adaptive designs.  We are thrilled to be bringing adaptive designs and exploration through simulations to NIH sponsored trials.  The links below provide additional details for this exciting opportunity.”

http://news.sciencemag.org/scienceinsider/2010/10/fdas-25-million-pitch-for-improving.html

http://www.nih.gov/news/health/sep2010/od-27.htm

http://projectreporter.nih.gov/project_description.cfm?projectnumber=1U01NS073476-01

http://nihroadmap.nih.gov/regulatoryscience/index.asp