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Abstract:
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Despite more than two decades of publications that offer more innovative model-based designs, the classical 3+3 design remains the most dominant phase I trial design in practice. In this talk, we introduce a new trial design, the Bayesian optimal interval (BOIN) design. The BOIN design is easy to implement in a way similar to the 3+3 design, but is more flexible for choosing the target toxicity rate and cohort size, and yields substantially better performance that is comparable to that of more complex model-based designs. The BOIN design contains the 3+3 design and the accelerated titration design as special cases, thus linking it to established phase I approaches. A numerical study shows that the BOIN outperforms the 3+3 and mTPI designs with higher probability of correctly selecting the maximum tolerated dose and a lower risk of inadequately dosing patients or treating them at toxic doses. We also discuss the BOIN design for drug combination trials. Freely available, open-source software (R package "BOIN") is provided to facilitate the application of the BOIN designs.
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