Weighing the Benefits of Adaptive Clinical Trial Designs – An Update

J0321067 As stated yesterday, there is a great deal of interest in the upcoming workshop on adaptive clinical trial design to be held in November in the Washington area.  While plans have not yet been finalized, here are some insights.

The conference, entitled "Adaptive Designs:  Opportunities, Challenges and Scope in Drug Development" is probably going to be held on November 13 and 14, for those who want to clear calendars now.  Those who put together the very comprehensive program are evenly balanced between FDA and industry.

What can be expected of this conference?  It would seem that the aim of the is to foster a discussion that helps put key stakeholders on the same page regarding the potential of adaptive designs and to help shape realistic expectations, moving the needle to consensus on to a very factually based understanding.  Therefore the first part of the conference will focus on the role of adaptive designs in actually improving efficacy and understanding scope of potential change as well as a substantial portion devoted to clearing up misunderstandings, both clinically and statistically, about adaptive clinical trial designs.   

The focus will then shift from the philosophical to the more practical elements respecting methodologies and designs.  This will be followed by an examination of what must be accomplished to pave the way for adaptive trial designs mixed with a further look at how various trial designs might be achieved. 

It would seem to be a very packed schedule, with long days planned and will likely be very well attended.  Advice is to book early and be happy this wasn’t held during the summer in Washington.

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