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Activity Number:
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199
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309609 |
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Title:
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Evaluating Treatment Effect in Randomized Trials with Learning Effect: An Application to Contraceptive Device Trials
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Author(s):
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Pai-Lien Chen*+
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Companies:
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Family Health International
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Address:
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PO Box 13950, Research Triangle Park, NC, 27709,
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Keywords:
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Abstract:
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Study participants in a randomized device trial must use study devices as designed to evaluate the true effect of devices. Nevertheless, the learning process of study devices is highly related to study outcomes and can be device-dependent. Without considering device-dependent learning effects, the conclusion of device trials will suffer potential bias. In this study we propose using a joint modeling approach to incorporate the learning effect into treatment effect evaluation. First, a generalized growth curve model is used to describe the leaning process, and then we use Cox's regression to model treatment effect for time to event outcomes with the integration of learning effect into the model. The parameters of the models will be estimated jointly by a semi-parametric method. A randomized contraceptive device trial will be used to illustrate the usefulness of the proposed method.
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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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