- 期刊
- OpenAccess
ON PERFORMANCE OF THE 3+3 DESIGN AND ITS MODIFIED VERSIONS FOR DOSE FINDING IN PHASE I CLINICAL TRIALS
摘要
Phase I clinical trial is the first step of testing drugs in humans. Clinicians often use the rule-based traditional 3+3 design to find the maximum tolerated dose. Since the design has many potential limitations, some modified versions of it are available in the literature to tackle those. However, no explicit comparison of these modified designs exist. In addition of comparing these designs among themselves, this paper also compares them with the model-based continual reassessment method. This is to see whether the modified versions can make a real difference with the original 3+3 design. Also, we would like to see how the modified versions work in comparison with the model-based continual reassessment method. Simulation studies show that all these rule-based designs do not differ much among themselves and also perform poorly compared to the continual reassessment method.
延伸閱讀
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