The rapid enrollment design for Phase I clinical trials.
The rapid enrollment design for Phase I clinical trials.
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DOI：
10.1002/sim.6886
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发表时间：
2016-07-10
影响因子：
2
通讯作者：
Foster MC
中科院分区：
文献类型：
--
作者：
Ivanova A;Wang Y;Foster MC
We propose a dose-finding design for Phase I oncology trials where each new patient is assigned to the dose most likely to be the target dose given observed data. The main model assumption is that the dose-toxicity curve is non-decreasing. This method is beneficial when it is desirable to assign a patient to a dose as soon as the patient is enrolled into a study. To prevent assignments to doses with limited toxicity information in fast accruing trials we propose a conservative rule that assigns temporary fractional toxicities to patients still in follow-up. We also recommend using a safety rule with any dose-finding method.
