ADVENT: An Adaptive Phase 3 Trial Resulting in FDA Approval of Crofelemer
*Lingyun Liu, Cytel Keywords: seamless, adaptive design, approval, regulatory, operational challenges Secretory diarrhea in HIV positive patients remains a serious unmet clinical need, even and especially in the age of highly active anti-retroviral therapy (HAART). In 2013 Crofelemer was approved by the FDA as a first-in-class anti-diarrheal agent indicated for the symptomatic relief of non-infectious diarrhea in adult HIV patients on anti-retroviral therapy (ART). The safety and efficacy of crofelemer were established through ADVENT, an innovative two-stage, seamless adaptive clinical trial with dose selection at the end of stage 1. In this talk we will highlight the clinical, statistical, regulatory and operational challenges of this adequate and well controlled trial. Its successful implementation reflects the high degree of precision with which the trial was planned and executed. To our knowledge this is the first example of an adaptive confirmatory trial with dose selection that has proceeded all the way to NDA submission and approval.
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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