One versus Two Adequate Studies for Providing Clinical Evidence of Effectiveness: Issues, concerns and benefits
*Jianliang Zhang, MedImmune Keywords: Requiring one confirmatory trial at alpha level 0.00125 is usually considered an equivalent alternative to the requirement of two independent adequate and well-controlled trials at alpha level 0.05. However, many conscious and unconscious assumptions are involved in reaching this alpha equivalence. This discussion will focus on potential issues and concerns regarding these assumptions. In addition, two technical findings will be discussed.
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Key Dates
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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