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Activity Number:
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522
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Type:
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Contributed
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Date/Time:
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Thursday, August 7, 2008 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300966 |
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Title:
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A New Approach To Monitor the Safety Risk in Clinical Trials
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Author(s):
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Chenxiong (Charles) Le*+ and Qing Liu
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Companies:
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MedImmune, Inc. and Johnson & Johnson Pharmaceutical R&D, LLC
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Address:
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1 MedImmune Way, Gaithersburg, MD, 20878,
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Keywords:
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Clinical trials ; sequential probability ratio test ; dose escalation ; cardiovascular
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Abstract:
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Monitoring safety risk is essential in clinical trials to protect patients and to reach decisions on dose selection. The traditional sequential probability ratio test (SPRT) is appropriate for short term safety endpoints, but it can be problematic when safety risk is monitored over a longer period of clinical evaluations. A new method, based on a reverse sampling, is proposed to monitor the safety risk, and the characteristics are investigated. This method is illustrated in an example in a large cardiovascular dose escalation study. The boundary of the SPRT is also investigated when the sample size is small.
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