Some notable properties of the standard oncology phase I design

Details Some notable properties of the standard oncology phase I design Some notable properties of the standard oncology phase I design

2008-08-03

arxiv.org/abs/0808.0359v2

Journal of Biopharmaceutical Statistics, Vol. 19, No. 3. (2009), pp. 543-555. by Gregory J Hather, Howard Mackey

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Scientific paper

We identify three properties of the standard oncology phase I trial design or 3 + 3 design. We show that the standard design implicitly uses isotonic regression to estimate a maximum tolerated dose. We next illustrate the relationship between the standard design and a Bayesian design proposed by Ji et al. (2007). A slight modification to this Bayesian design, under a particular model specification, would assign treatments in a manner identical to the standard design. We finally present calculations revealing the behavior of the standard design in a worst case scenario and compare its behavior with other 3 + 3-like designs.

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