FDA Industry Session Features Panel on "Seamless Adaptive Designs"

Posted by Cytel

Sep 16, 2014 3:30:00 PM

An FDA Industry Statistics Workshop on September 23 will feature a panel on seamless adaptive designs. Seamless adaptive designs are studies which are able to combine two stages of a clinical trial into one adaptive study, thereby cuting trial costs and reducing study length. The panel will feature Cytel Statistician Lingyun Liu,Lisa Kammerman of AstraZeneca, and Joshua Chen of Merck. The FDA's Sue-Jane Wang will be the featured discussant.

Lingyun will discuss Cytel's design of the successful ADVENT trial, a seamless adaptive trial for Crofelemer. The trial began as a four arm trial and during interim analysis, the two suboptimal doses were dropped. As a result, the trial was able to perform dose-selection before moving on to the confirmatory stage with only two arms. 

Lingyun writes in her abstract:

"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."

Topics: Cytel Consulting, Adaptive Clinical Trials

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