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Activity Number:
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23
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Type:
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Contributed
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Date/Time:
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Sunday, August 11, 2002 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section*
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| Abstract - #301955 |
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Title:
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Issues in Statistical Assessment of Efficacy and Safety in Special Patient Populations
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Author(s):
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Yi Tsong*+
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Affiliation(s):
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Food and Drug Administration
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Address:
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5600 Fishers Lane, 15B45, Rockville, Maryland, 20857, USA
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Keywords:
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Equivalence ; Special Patient Population ; Bridging Study
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Abstract:
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Assessment of treatment efficacy or safety in a specific patient population is one of the important issues in NDA development and regulatory review. Based on different regulatory needs, the objective of such studies varies correspondingly. Interest in efficacy and safety assessment of a test treatment in a special patient population may be generated before the planning of the NDA clinical trials or after NDA approval. Such consideration may arise in the form of subgroup analysis in clinical trial; for instance, in evaluation of drug efficacy in pediatric patients, female patients or the US region in an international study. It may also arise in the form of a bridging study when the efficacy has been demonstrated in the original population before extending to a special population. In this presentation, we surveyed the objectives, designs and analysis methods and the issues involved with the approaches.
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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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