Adaptive Clicial Trials and Data Monitoring Committees: One View from the World of Medical Devices
*Greg Campbell, Consultant Keywords: adaptive design, medical devices, data monitoring committee, firewalls The FDA guidance document on Data Monitoring Committees was finalized in 2006. In the meantime, the importance, use and experience associated with adaptive designs have grown enormously. FDA has issued two draft guidance documents on adaptive designs, one for drugs and biologics in 2010 and another, more recently, for medical devices in 2015. While the 2006 guidance on DMCs carefully lays out the principles for the establishment and operation of data monitoring committees for clinical trials, this talk will briefly review the 2006 document on DMCs in terms of the potential impact on adaptively designed clinical trial trials. The draft guidance on adaptive designs for medical devices will be reviewed in terms of those areas likely to impact the roles, responsibility and operation of DMCs. Possible changes to the DMC document to reflect the challenges that adaptive designs can make to the operation and responsibility of DMCs will be considered.
|
Key Dates
-
June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC