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Activity Number:
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263
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Type:
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Invited
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Date/Time:
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Wednesday, August 14, 2002 : 8:30 AM to 10:30 AM
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Sponsor:
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Section on Risk Analysis*
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| Abstract - #300177 |
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Title:
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Risk Assessment Modeling in Clinical Trials
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Author(s):
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Joseph Costantino*+
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Affiliation(s):
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University of Pittsburgh
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Address:
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201 N. Craig Street, Suite 350, Pittsburgh, Pennsylvania, 15213, USA
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Keywords:
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risk assessment ; breast cancer risk ; risk-benefit analysis
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Abstract:
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Risk assessment modeling can be used in three aspects of clinical trials designed to evaluate the efficacy of therapies to treat or prevent a disease. First, individualized estimates of absolute risk of a particular disease of interest can be used to identify potential trial participants who would be at high risk for the disease. Second, individual-based risk/benefit assessments can be used as part of the informed consent process to communicate to trial participants the composite of potential risks and benefits anticipated for them by the use of the therapy being evaluated in the trial. Third, a population-based benefit/risk assessment can be used as a global approach to monitoring the overall safety in the trial. The statistical methodologies recently used for the three types of risk assessment are described; and the STAR trial, a clinical trial involving the evaluation of therapies to reduce the risk of breast cancer, is used to illustrate examples of implementation.
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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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