|
TL03: Adaptive Design’s Past, Current, and Future
*Xiaoyin (Frank) Fan, Vertex Pharmaceutical Keywords: Adaptive design (AD) has evolved a long way from just a few specific types of designs to a more inclusive collection of innovative trial designs. Its usefulness has also been well recognized in the pharmaceutical industry. This round table discussion is intended to discuss the following topics: •To share program or portfolio level approaches of using AD among pharmaceutical companies. For example: o How much effort/resource is invested in the developing and considering AD in trials; o Roughly how popular AD is in late-stage trials among different therapeutic areas and trial phases; o How to balance the need to be adaptive in conducting the trial and the challenges in operational implementations plus difficulties in interpretation of the results; o What are the practices to engage with regulatory agencies when considering AD; • To learn about some feedback to the recent FDA draft guidance for Industry, particularly with regard to any changes in their approaches and practices in design and/or conduct of AD trials (2010)
|
Key Dates
-
November 1, 2012
Online submission opens for session, short course, roundtable luncheon discussion, and Town Hall proposals -
December 31, 2012
Online submission for a session, short course, and Town Hall proposals closes @ 11:59 pm EDT -
February 12, 2013
Organizing/Planning Meeting, Shady Grove, MD -
March 1, 2013
Roundtable submission closes @ 11:59 pm EDT -
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC









