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Activity Number:
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175
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Type:
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Roundtables
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Date/Time:
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Monday, August 3, 2009 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303433 |
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Title:
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Pooling versus No Pooling of Safety Data from Clinical Trials
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Author(s):
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Vipin Arora*+
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Companies:
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Takeda Pharmaceuticals
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Address:
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675 North Field Drive, Lake Forest, IL, 60045,
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Keywords:
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Cardiovascular ; Safety ; Diabetes ; Meta analysis ; Pooling ; Clinical Trials
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Abstract:
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Assessment of CV risk for New Anti-Diabetes Therapies needs diligent planning by sponsors. In view of recent FDA guidance (December 2008), the Safety clinical trials are to be designed to compare the incidence of important cardiovascular events occurring with investigational compound to the incidence of the same type of events occurring with the control group to demonstrate that the upper bound of the two-sided 95 percent confidence interval for the estimated risk ratio is less than 1.8 (for example). This can be achieved as a result of a stand alone Safety trial to collect enough CV events or by pooling CV events across completed studies using a meta analysis approach. Each approach has its pros and cons. What are the overall risks associated with each approach for sponsor and subjects? Details and experiences of participants will be discussed during the luncheon.
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