JSM 2015 Preliminary Program

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Activity Number: 44
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317183 View Presentation
Title: Continual Reassessment Method Under Model Uncertainty
Author(s): Tobias Mielke*
Companies: ICON PLC
Keywords: CRM ; Dose Escalation ; Bayesian
Abstract:

Dose escalation designs are frequently used in early stage clinical development for the determination of the maximum tolerated dose. Various approaches exist to escalate as quickly and safe as possible to the targeted dose level. Model-free approaches, as the 3+3 design are frequently used, but may be of limited efficiency and efficacy for certain underlying dose-toxicity curves. Bayesian dose escalation designs allow the inclusion of prior information for an optimized escalation towards the dose with a targeted rate of toxic events. However, the considered continual reassessment methods consider one underlying dose-toxicity shape. Getting this shape wrong may decrease the quality of the design. Benefits and risks of the application of weighted sets dose-toxicity assumptions for the continual reassessment method will be studied in this presentation. A simulation study will compare the considered dose-escalation design with standard approaches as the 3+3 design, the modified toxicity probability approach and the two-parameteric logistic regression design with overdose-control.


Authors who are presenting talks have a * after their name.

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