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Activity Number:
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631
- Clinical Trial Design- 7
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Type:
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Contributed
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Date/Time:
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Thursday, August 2, 2018 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #328300
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Title:
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Target Toxicity Design for Phase 1 Dose-Finding: a Safe and Reliable Method
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Author(s):
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Bob Zhong* and Wenchuan Guo
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Companies:
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Johnson and Johnson and University of California Riverside
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Keywords:
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Group sequential designs;
Dose-finding;
Phase 1;
MTD;
Recommended phase 2 doses;
Power
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Abstract:
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We propose a new two-/three-stage dose-finding design called Target Toxicity (TT) for Phase 1 clinical trials, where we link the decision rules in the dose-finding process with the conclusions from a hypothesis test. The power to detect excessive toxicity is also given. This solves the problem why the maximum number of patients is needed for each dose level. Our method provides statistical explanation of traditional ``3+3'' design using frequentest framework. This method is very flexible and it incorporates other interval-based decision rules through different parameter settings. We provide the decision table to guide investigators when to decrease, increase or repeat a dose for next cohort of subjects. We conduct simulation experiments to compare the performance of the proposed method with other dose-finding designs. A free open source R package tsdf is available on CRAN. It is dedicated to derive two-/three-stage design decision tables and perform dose-finding simulations.
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Authors who are presenting talks have a * after their name.
