Optimal Interval Design for Phase I Oncology Clinical Trials

Bryan Fellman () and Ying Yuan
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Bryan Fellman: MD Anderson Cancer Center
Ying Yuan: MD Anderson Cancer Center

2014 Stata Conference from Stata Users Group

Abstract: The optimal interval design is a novel phase I trial design for finding the maximum tolerated dose (MTD). The optimal interval design casts dose finding as a sequential decision making problem for assigning an appropriate dose for each enrolled patient. The design optimizes the assignment of doses to patients by minimizing incorrect decisions of dose escalation/deescalation, i.e., erroneously escalating (or deescalating) the dose when the current dose is actually higher (or lower) than the MTD. This feature of the optimal interval design strongly ensures adherence to ethical standards. In addition, as the optimal dose assignment tends to treat patients at (or close to) the MTD, at the end of the trial, this design will be able to select the MTD with a high probability because most data and statistical power are concentrated around the MTD. This presentation will briefly cover the methods of the design and demonstrate a command that implements them in a clinical setting.

Date: 2014-08-02
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