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Abstract Details
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Activity Number:
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531
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300789 |
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Title:
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Practical Use of Historical Controls in Clinical Trials for Rare Diseases
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Author(s):
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Jeongsook "Jessica" Kim*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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CBER, Rockville, MD, 20852,
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Keywords:
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historical control ;
rare disease ;
meta-analysis ;
clinical trial
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Abstract:
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In certain clinical trials, one may encounter situations where no active controls are available. In designing such studies, both placebo controls and historical controls have been used as comparators. Understanding historical control rates of some event may present a challenge to the drug development process due to innovations in medical treatments or changes in medical practice over time and the comparability of the specific target patient populations. We will discuss statistical considerations in determining appropriate historical controls for such situations.
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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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