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Activity Number:
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103
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 3, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303955 |
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Title:
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Can We Combine Multiple Condition of Approval Studies?
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Author(s):
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Shelby Li*+ and An Liu and Hongyan Qiao and Scott McRae
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Companies:
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Medtronic, Inc. and Medtronic, Inc. and Medtronic, Inc. and Medtronic, Inc.
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Address:
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8200 Coral Sea St NE, Mounds View, MN, 55112,
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Keywords:
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Condition of Approval ; Clinical Trial ; Post-market Study ; Medical Device ; Design
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Abstract:
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Increasingly, more resources are required to mange Condition of Approval follow-up studies that evaluate long-term safety of medical devices. These studies require a relatively larger sample size, and longer follow-up time. Managing multiple large-scale post-approval clinical studies could become burdensome to both study sponsors and study centers. Patients who have cardiac pacing or defibrillating systems implanted often receive multiple device components. Therefore, two or more device components may be enrolled in different post-approval studies simultaneously. Combining multiple post-approval clinical studies can be a good approach to reduce trial management burden. Advantages and challenges of designing a clinical trial that satisfies requirements for multiple Condition of Approval studies will be discussed in this talk.
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