TL16: Comparative effectiveness in off-label indications
*Jason Connor, Berry Consultants Keywords: Many approved therapies are commonly used off-label. However, when academic sponsors seek to compare commonly used off-label treatments head-to-head, an IND from FDA is necessary. In such comparative effectiveness research (CER) trials the research question and design strategy often differ from a typical registration study. For example, a placebo is frequently not ethical. Also the definition of a Type I error is less clear in a 3 or more arm trial that is not placebo-controlled. Furthermore a typical research question is "which treatment is best", not necessarily a question of statistical hypothesis test. Finally the primary aims may be multivariable, including simultaneous considerations of effectiveness (not necessarily efficacy), safety, and quality of life. Each of these considerations differs from standard industry-sponsored registration trials. In this session we propose an academic investigator involved in NIH-funded CER trials to discuss goals of such CER trials and an FDA reviewer to discuss how FDA treats (or doesn't treat) these trials differently from industry-sponsored trials seeking labeling.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC