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Activity Number:
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431
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 6, 2008 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301517 |
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Title:
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Effective Interactions of the DMC, Steering Committee, and Sponsor in a Long-Term Prevention Trial
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Author(s):
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Michelle McNabb*+ and Janet Wittes
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Companies:
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Eli Lilly and Company and Statistics Collaborative, Inc.
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Address:
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Lilly Corporate Center, Indianapolis, IN, 46285,
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Keywords:
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DMC ; clinical trials ; data monitoring
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Abstract:
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Long-term prevention trials present special data monitoring challenges and opportunities. This is especially true when medical advancements in disease assessment and treatment are rapidly evolving. The RUTH (Raloxifene Use for the Heart) trial studied over 10,000 post-menopausal women at high risk for cardiovascular events for seven years. Effective communication between the DMC, steering committee and sponsor was essential to preserving the scientific integrity of the trial while allowing for modifications to the trial in response to new information external to the trial. Recommended practices based upon the RUTH trial will be presented from the trial statistician's and DMC chair's perspectives.
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