Activity Number:
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46
- Recent Developments in Novel Clinical Trial Design and Analysis for Precision Medicine
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Type:
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Invited
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Date/Time:
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Sunday, July 28, 2019 : 4:00 PM to 5:50 PM
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Sponsor:
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ENAR
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Abstract #300008
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Presentation
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Title:
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Bayesian Clinical Trial Designs to Evaluate Subgroup-Specific Treatment Effects
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Author(s):
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Peter Thall* and Juhee Lee and Thomas Murray and Andrew Chapple
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Companies:
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U.T. M.D. Anderson Cancer Center and University of California, Santa Cruz and University of Minnesota and Louisiana State University
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Keywords:
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Clinical trial design;
Utility;
Precision medicine;
Bayesian design;
Cancer clinical trial
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Abstract:
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This talk will present three Bayesian clinical trial designs in which outcome adaptive decisions are made within predefined prognostic subgroups. The first is a randomized trial comparing nutritional prehabilitation to standard of care for controlling post-operative morbidity (POM) following chemoradiation and esophageal resection. The design accounts for two prognostic subgroups while assuming a robust generalization of proportional odds model for POM as a function of treatment and subgroup. The second is a phase I design to optimize dose based on time to toxicity that generalizes the time-to-event continual reassessment method, while allowing adaptive combination of subgroups having similar dose-toxicity profiles. The third is a phase I-II trial of natural killer cells for advanced hematologic malignancies that does dose optimization and sequential safety monitoring within six prognostic subgroups, based on five time-to-event outcomes. All designs are shown by simulation to be greatly superior to their conventional comparators.
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Authors who are presenting talks have a * after their name.