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Activity Number: 699
Type: Contributed
Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #316623
Title: WITHDRAWN: Re-Think 'Stop for Success' in the Interim Analysis of a Regional Clinical Trial
Author(s): Bingming Yi and Linda Luo and Jack Peng
Companies: GSK Shanghai and GSK Shanghai and GSK Shanghai
Keywords: Stop for Success ; Interim analysis ; regional clinical trial ; adaptive design
Abstract:

In a clinical trial, decisions of stop for futility and stop for success can be made in the interim analysis to save cost and be ethical. But FDA and EMEA generally discourage the idea of stop for success in the interim of a trial due to concerns on insufficient data on safety and/or efficacy. However, for a regional clinical trial which is usually conduct after a regulatory approval has been granted by FDA and/or EMEA, and sufficient data on safety and efficacy have been accumulated for the asset. It is rationale to re-think benefits of making a decision of stop for success in a regional clinical trial. An example will be provided to illustrate this concept. Considerations are also needed to take into account to meet local regulatory guidance such as specific sample size requirement to collect sufficient information.


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