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Abstract Details
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Activity Number:
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473
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300970 |
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Title:
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A Multivariate Performance Function for Comparing Phase I Dose Escalation Designs
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Author(s):
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Dominik Heinzmann*+
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Companies:
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F. Hoffmann-La Roche Ltd.
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Address:
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Malzgasse 30, Basel, 4070, Switzerland
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Keywords:
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dose escalation designs ;
conditional probability of success ;
comparison
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Abstract:
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In Phase I dose escalation trials in Oncology, different designs as the traditional 3+3 method, the continual reassessment method or even more sophisticated methods jointly modeling safety and efficacy (e.g. biomarker) can be applied to find an appropriate dose for an investigational drug. These designs can be compared with respect to measures such as sample size, trial duration, accuracy and precision of the estimated "optimal" dose. In this paper, a unified measure is introduced enabling assessment of the overall performance of dose escalation designs. This holistic function enables comparison of the designs. It incorporates the conditional probability of success in a sequential Phase II trial given the selected dose in the Phase I to adjust sample size for estimation accuracy and precision. Simulation studies indicate that this performance function is a valuable tool for selecting an appropriate dose escalation method for a new drug. In particular, the function can be useful to evaluate if biomarker information should be included into the dose escalation framework.
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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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