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    Bayesian adaptive designs for non-inferiority and dose selection trials.

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    Baylor University access only
    Date
    2006-07-31
    Author
    Spann, Melissa Elizabeth.
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    Abstract
    The process of conducting a pharmaceutical clinical trial often produces information in a way that can be used as the trial progresses. Bayesian methods offer a highly flexible means of using such information yielding inferences and decisions that are consistent with the laws of probability and consequently admit ease of interpretation. Bayesian adaptive sampling methods offer the potential to accelerate the investigation of a drug without compromising the safety of the trial’s participants. These methods select a patient’s treatment based upon prior information and the knowledge accrued from the trial to date which can reduce patient exposure to unsafe or ineffective treatments and therefore improve patient care in clinical trials. Improving the process of clinical trials in this manner is beneficial to all involved including the pharmaceutical companies and more especially the patients; safer and less expensive drugs can make it to market faster. In this research we present a Bayesian approach to determining if an experimental treatment is non-inferior to an active control treatment within a clinical trial that includes a placebo arm. We incorporate this non-inferiority model in a Bayesian adaptive design that uses joint posterior predictive probabilities of safety and efficacy to determine adaptive allocation probabilities. Results from a retrospective study and a simulation are used to illustrate use of the method. We also present a Bayesian adaptive approach to dose selection that uses effect sizes of doses relative to placebo to perform adaptive allocation and to select the most efficacious dose. The proposed design removes treatment arms if their performance relative to placebo or other treatment arms is undesirable. Results from analyses of simulated data will be discussed.
    URI
    http://hdl.handle.net/2104/4207
    Department
    Statistical Sciences.
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    • Theses/Dissertations - Statistical Sciences

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    Copyright © Baylor® University All rights reserved. Legal Disclosures.
    Baylor University Waco, Texas 76798 1-800-BAYLOR-U
    Baylor University Libraries | One Bear Place #97148 | Waco, TX 76798-7148 | 254.710.2112 | Contact: libraryquestions@baylor.edu
    If you find any errors in content, please contact librarywebmaster@baylor.edu
    DSpace software copyright © 2002-2016  DuraSpace
    Contact Us | Send Feedback
    TDL
    Theme by 
    Atmire NV