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Activity Number:
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133
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309624 |
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Title:
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When To Stop a Clinical Trial for Efficacy?
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Author(s):
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Vipin Arora*+
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Companies:
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Novartis Pharmaceuticals
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Address:
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One Health Plaza, East Windsor, NJ, 07936-1016,
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Keywords:
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Stopping boundaries ; Clinical Trials ; Interim analysis ; Patient ; Sponsor
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Abstract:
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Stopping boundaries are pre-specified for clinical trials with interim analyses (IA) and detailed in the Data Monitoring Committee (DMC) Charter. These boundaries should be stringent enough to protect patient and sponsor interests in demonstrating positive efficacy before normal completion of the study. O'Brien-Fleming (O-F), Haybittle-Peto (H-P), Pocock family type boundaries are common choices. Selection of stopping boundaries may impact the patient and sponsor interests due to early trial termination. Experienced DMCs are very well aware of their responsibility and their assessment is based on totality of evidence. Most commonly, H-P type boundaries are used when there are serious ethical concerns and the O-F are used when the intentions of stopping are genuine. Examples based on these two methods to safeguard interest of all stakeholders including patient and sponsor will be presented.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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